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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5193

2. Registrant Information.

Registrant Reference Number: 2454711

Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.

Address: 160 QUARRY PARK BLVD. SE Suite 200

City: CALGARY

Prov / State: AB

Country: Canada

Postal Code: T2C 3G3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-JUN-19

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 432-1363

Product Name: Tempo SC Ultra

  • Active Ingredient(s)
    • BETA-CYFLUTHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Blood
    • Symptom - Hypoglycemia
    • Symptom - Leukocytosis
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Cardiovascular System
    • Symptom - Other
    • Specify - Cardiac hypertrophy
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Respiratory System
    • Symptom - Shortness of breath

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Pain
  • Nervous and Muscular Systems
    • Symptom - Muscle weakness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Euthanised / Euthanasie

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

10.00

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Died

16. How was the animal exposed?

Other / Autre

specify Defined point of exposure not evident or witnessed. Exposure based on speculation.

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

6/4/2019 The following report was forwarded to documentation. The report states that a pest control operator has provided 6 quarterly services to consumer using the diluted product as crack and crevice and localized spot treatments on the interior. The last quarterly service was 3/28/2019, and on 5/9/2019 they provided a re-spray for bugs inside per customer request. Consumer called the office on 5/28/2019 stating that one of her dogs died. Consumer keeps the dogs in a separate room and out of the treated area until the material is allowed to dry. on 5/29/2019, consumer called again saying another dog is ill. Consumer sent an email stating that the dog has died. Called consumer to talk about her dogs. Consumer moved to the home a little over a year ago, and five dogs have died since the moved. Her dogs are all shih tzus around 10 pounds, but not related. One dog died today, preceded by hypoglycemia and high white blood cell count. He did not respond to intravenous antibiotics. The veterinarian suspected a brain tumor. Another dog died 5/28/2019. On necropsy, and enlarged heart and thickened heart muscle were found. Another dog died 3/21/2019 preceded by abnormal breathing. No necropsy was performed. Another dog died on 11/10/2017 preceded by anorexia, weakness, and severe spinal pain. She was euthanized by an emergency veterinarian. Another dog died on 2/12/2019. This dog was geriatric, and caller attributes the death to old age.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

The product was heavily diluted prior to use in this case and if ingested by the dogs, only minor oral irritation or GI upset would be expected. The signs reported for all five dogs, including death, are not expected following exposure to this product. Other causes including underlying cancer, heart disease, spinal injury or disease (IVDD, FCE), conformational issues leading to respiratory signs (severe brachycephalic syndrome), should be considered. One dog did have a necropsy with an enlarged heart and heart muscles noted, making heart disease and blood clot formation a far more likely contributor to death.