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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-0792

2. Registrant Information.

Registrant Reference Number: 130139288

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

04-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

01-OCT-13

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. 2724-777-270

Product Name: Adams Carpet Powder With Linalool and Nylar

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .075 %
    • PYRIPROXYFEN
      • Guarantee/concentration .02 %

7. b) Type of formulation.

Dust

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Res. - Out Home / Rés - à l'ext.maison

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

On September 30, 2013 the owner's wife inappropriately sprinkled the product in the yard, where the puppies were kept in a pen. The puppies did not return to the pen until the evening of October 1, 2013, when they may have been exposed to the product.

To be determined by Registrant

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

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Polydipsia
    • Symptom - Lethargy
    • 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?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On the evening of October 1, 2013, shortly after being introduced to the treated area, the owner noticed that the puppy was polydipsic. On October 2, 2013 the owner took the puppy to the veterinarian, where a physical exam was done, but no diagnostics were done; the puppy then went back home. On October 3, 2013 the puppy was adopted by someone else, who informed the owner that the puppy was lethargic that evening. On October 4, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian said that the severity of signs the puppy was experiencing would not be expected. The APSS veterinarian recommended that the owner take the puppy to the veterinarian and have the veterinarian call for information.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On October 7, 2013 an APSS assistant called the owner to update the case. The owner stated that on October 5, 2013 the puppy was taken to the veterinarian, where he was diagnosed with Parvovirus; that day, the puppy died. The APSS veterinarian stated that Parvovirus was considered to have a high likelihood of causing the clinical situation. A necropsy was not available. Extra Label Use: Indoor product used outdoors and area not vacuumed.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Polydipsia
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Vomiting
  • General
    • Symptom - Weakness
    • 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?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On the evening of October 1, 2013, shortly after being introduced to the treated area, the owner noticed that the puppy was polydipsic. On October 2, 2013 the owner took the puppy to the veterinarian, where a physical exam was done, but no diagnostics were done; the puppy then went back home. On October 3, 2013 the owner noticed that the puppy was lethargic. On October 4, 2013 the owner noticed that the puppy was inappetent, vomiting, and weak; at that time, the owner started giving the puppy an oral electrolyte solution between episodes of vomiting and giving the puppy a liquid Bismuth Subsalicylate product to treat the puppy. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if the product was ingested, self-limiting gastrointestinal (GI) upset could be seen. The APSS veterinarian said that the severity of signs the puppy was experiencing would not be expected. Regarding the liquid Bismuth Subsalicylate product, the APSS veterinarian stated that if enough was given, GI ulcers or liver effects could be seen from the aspirin in the product. The APSS veterinarian recommended that the owner take the puppy to the veterinarian, have the veterinarian call for information, and discontinue giving the liquid Bismuth Subsalicylate product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the carpet powder product and the liquid Bismuth Subsalicylate product were not considered to be related to causing the clinical situation. On October 7, 2013 an APSS assistant called the owner to update the case. The owner stated that on October 5, 2013 the puppy was taken to the veterinarian, where he was diagnosed with Parvovirus; that day, the puppy died. The APSS veterinarian stated that Parvovirus was considered to have a high likelihood of causing the clinical situation. A necropsy was not available. Extra Label Use: Indoor product used outdoors and area not vacuumed.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Polydipsia
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Vomiting
  • General
    • Symptom - Weakness
    • 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?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On the evening of October 1, 2013, shortly after being introduced to the treated area, the owner noticed that the puppy was polydipsic. On October 2, 2013 the owner took the puppy to the veterinarian, where a physical exam was done, but no diagnostics were done; the puppy then went back home. On October 3, 2013 the owner noticed that the puppy was lethargic. On October 4, 2013 the owner noticed that the puppy was inappetent and vomiting; at that time, the owner started giving the puppy an oral electrolyte solution between episodes of vomiting and giving the puppy a liquid Bismuth Subsalicylate product to treat the puppy. That evening the owner noticed that the puppy was very weak and unable to get up. A short time later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if the product was ingested, self-limiting gastrointestinal (GI) upset could be seen. The APSS veterinarian said that the severity of signs the puppy was experiencing would not be expected. Regarding the liquid Bismuth Subsalicylate product, the APSS veterinarian stated that if enough was given, GI ulcers or liver effects could be seen from the aspirin in the product. The APSS veterinarian recommended that the owner take the puppy to the veterinarian, have the veterinarian call for information, and discontinue giving the liquid Bismuth Subsalicylate product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the carpet powder product and the liquid Bismuth Subsalicylate product were not considered to be related to causing the clinical situation. On October 7, 2013 an APSS assistant called the owner to update the case. The owner stated that on October 5, 2013 the puppy was taken to the veterinarian, where he was diagnosed with Parvovirus; that day, the puppy died. The APSS veterinarian stated that Parvovirus was considered to have a high likelihood of causing the clinical situation. A necropsy was not available. Extra Label Use: Indoor product used outdoors and area not vacuumed.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Border Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

15.0

lbs

8. Route(s) of exposure

Skin

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 - Polydipsia
  • Gastrointestinal System
    • Symptom - Loss of appetite
  • General
    • Symptom - Lethargy
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

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

On the evening of October 1, 2013, shortly after being introduced to the treated area, the owner noticed that the puppy was symptomatic. Early on the morning of October 2, 2013 the owner observed that the puppy had died. On October 4, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk if the product was ingested, self-limiting gastrointestinal (GI) upset could be seen. The APSS veterinarian said that the severity of signs the puppy experienced would not be expected. A necropsy was not available.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Puppies were all diagnosed with Parvovirus. Extra Label Use: Indoor product used outdoors and area not vacuumed.