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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6461

2. Registrant Information.

Registrant Reference Number: 130124233

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-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

30-AUG-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. 2724-488

Product Name: Zodiac Spot On Flea Control For Cats And Kittens

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 August 26, 2013 the owner bathed the cat with a shampoo product and then applied the spot on product 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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

12.0

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

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Heavy breathing
    • Symptom - Panting
  • Gastrointestinal System
    • Symptom - Inappropriate defecation
  • 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 August 30, 2013 the owner noticed that the cat was lethargic, had an isolated seizure that lasted about 15 seconds, and was anorexic. On September 2, 2013 the owner noticed that the pet was breathing heavily; his breathing seemed labored and his respiratory rate was fast. On September 3, 2013 the owner observed that the cat was panting, experienced inappropriate defecation, and then immediately died. On September 4, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Methoprene is an insect growth regulator (IGR) with a wide margin of safety and that topical exposures would be unlikely to cause any significant signs. The APSS veterinarian recommended that the owner have a necropsy done and call 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

The APSS veterinarian stated that the products were considered to have a doubtful likelihood of causing the clinical situation. On the afternoon of September 4, 2013 the owner called the APSS to update the case; she stated that the animal welfare department could not do a necropsy. However, later that day the owner contacted the APSS again and stated that she would have a necropsy done after all. Teh necropsy revealed the presence of severe hypertrophic cardiomyopathy which was the likely cause of death.