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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4409

2. Registrant Information.

Registrant Reference Number: 130079491

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

05-JUN-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. 2724-814

Product Name: Kirkland Signature Flea And Tick Control For Cats 5lbs and over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

Units: mL

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 May 29, 2013 the owner applied the product to the cat to treat for fleas.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

6.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Lesion
    • Specify - Abscess
  • Eye
    • Symptom - Blindness (temporary)
    • Symptom - Pupil dilation
  • General
    • Symptom - Hyperthermia
    • Symptom - Other
    • Specify - Walking Aimlessly
  • Gastrointestinal System
    • Symptom - Weight loss
  • 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?

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 June 5, 2013 the owner noticed that the cat was symptomatic. On June 7, 2013 the owner took the cat to the veterinarian, where a diagnostic evaluation was done, the abscess was treated, and the cat was started on antibiotics. On June 10, 2013 the cat's only remaining symptom was dilated pupils. On June 13, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The owner stated that she was on her way to see her regular veterinarian and the APSS assistant noted that additional information should be obtained regarding this case. The owner also stated that she had taken the cat to the veterinarian a second time on June 15, 2013 and the cat was given B vitamins. The APSS veterinarian stated that the cat's signs were not really consistent with use of the product and that toxoplasma and possibly retroviruses should be considered by the owner's regular veterinarian.


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 related to the clinical situation. On June 21, 2013 an APSS veterinarian contacted the owner to update the case. The owner stated that the cat had lost a pound in a week. The APSS veterinarian recommended that the owner's regular veterinarian call for information. On June 28, 2013 the owner's regular veterinary staff called the APSS to update the case. The owner's regular veterinary staff stated that the cat died on the evening of June 27, 2013. The APSS veterinarian recommended that the owner's regular veterinarian contact the owner to see if she wanted to pursue a necropsy; the owner's regular veterinary staff stated that they would contact the owner and call back. On June 28, 2013 an APSS assistant contacted the clinic. The owner's regular veterinary staff stated that the owner was unsure if she wanted to pursue a necropsy at that time and that they would call back later if they decided to pursue a necropsy. The owner never called back and a necropsy was not performed, so the cause of death is unknown.