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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2009-5446

2. Registrant Information.

Registrant Reference Number: 090081216

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.

20-JUL-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

10-JUL-09

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. 2724-401

Product Name: Zodiac Fleatrol Carpet and Upholstery Pump Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .01 %
    • PERMETHRIN
      • Guarantee/concentration .28 %

7. b) Type of formulation.

Liquid

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).

The pet owner treated the area inside his home with the product on or around June 22, 2009, July 13, 2009, and July 19, 2009.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Rigidity
  • Respiratory System
    • Symptom - Runny nose
    • Specify - Nasal Discharge
  • General
    • 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 July 20, 2009, the pet owner found the cat with muscle rigidity and nasal discharge. Within 5 minutes the cat died. The pet owner contacted the Animal Product Safety Service (APSS) that same morning. The APSS veterinarian stated that significant signs would not be expected with an exposure to the product after it had dried. If the cat had been exposed to the product before it was dry, gastrointestinal upset would be possible with ingestion. Tremors and seizures would be unlikely with the concentration of permethrin in this product. The APSS veterinarian recommended that the owner have a necropsy and hair testing performed to establish a cause of death. The owner agreed to take the cat's body to his veterinarian and have the veterinarian call for instructions.


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. The following information was given after the original report was written. On July 25, 2009 an APSS veterinarian spoke to the pathologist regarding the results of necropsy. The pathologist's findings included pleomorphic plasma cells in the spleen, lymph nodes, and liver, consistent with multiple myeloma. Centrilobular hepatocellular degeneration consistent with hyperviscosity syndrome secondary to multiple myeloma was also present. Hair testing results are pending.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Respiratory System
    • Symptom - Runny nose
    • Specify - Nasal Discharge
  • General
    • 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 July 17, 2009, the cat was recumbent. On July 18, 2009, the cat had nasal discharge. The cat died that same evening. The pet owner contacted the Animal Product Safety Service (APSS) on July 20, 2009. The APSS veterinarian stated that significant signs would not be expected with an exposure to the product after it had dried. If the cat had been exposed to the product before it was dry, gastrointestinal upset would be possible with ingestion. Tremors and seizures would be unlikely with the concentration of permethrin in this product. The cat's body was not available for necropsy.


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. A follow up was not performed for this patient, because additional information was not expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • 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 July 10, 2009 the pet owner found the cat seizing. The cat died within 5 minutes. On July 20, 2009 the pet owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that significant signs would not be expected with an exposure to the product after it had dried. If the cat had been exposed to the product before it was dry, gastrointestinal upset would be possible with ingestion. Tremors and seizures would be unlikely with the concentration of permethrin in this product. At the time of the call, the cat's body was not available for necropsy.


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. A follow up was not performed for this patient, because additional information was not expected.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

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.

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 July 22, 2009, the pet owner found the cat dead. The pet owner had contacted the Animal Product Safety Service (APSS) two days before to discuss other patients and called again after this cat died. The APSS veterinarian stated that significant signs would not be expected with an exposure to the product after it had dried. If the cat had been exposed to the product before it was dry, gastrointestinal upset would be possible with ingestion. Tremors and seizures would be unlikely with the concentration of permethrin in this product. The pet owner declined a necropsy for this cat.


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. A follow up was not performed for this patient, because additional information was not expected.