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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0861

2. Registrant Information.

Registrant Reference Number: 100154486

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.

01-DEC-10

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

01-DEC-10

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. 2724-404-270

Product Name: Bio Spot Flea and Tick Spray for Cats and Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

Other Units: sprays

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

Site: Animal / Usage sur un animal domestique

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

On December 1, 2010 the owner sprayed a small amount of the product onto the cat.

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

Cat / Chat

3. Breed

Siamese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Bloody vomit
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Heavy breathing
  • 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On December 1, 2010 the owner noticed a few minutes after the product was applied, that the cat became symptomatic. The cat then died from what the owner described as convulsing so violently that she snapped her own neck. The owner attempted cardiopulmonary resuscitation (CPR), but was unsuccessful. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated signs are consistent with anaphylactic reaction, which is generally not expected with dermal application. The APSS veterinarian also stated that she has never seen fatal anaphylactic reaction with dermal application of low concentration of pyrethrins. The APSS veterinarian further stated the need to rule out hypertrophic cardiomyopathy, etc. The APSS veterinarian recommended taking the cat's body to the veterinarian, have the veterinarian call for information on a necropsy, and calling back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On December 1 and 2, the APSS staff had several contacts with the attending veterinary clinic. The final necropsy report was received on December 19, 2010. The necropsy revealed significant pathology in several organs including the heart. The final histological evidence supports the diagnosis of an underlying cardiomyopathy which likely resulted in death.