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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-4455

2. Registrant Information.

Registrant Reference Number: 100105855

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-AUG-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-AUG-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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control for Cats and Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

Other Units: drops

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 8, 2010 the owner inappropriately applied the product onto the kitten.

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

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.269

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Weakness
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Urinary incontinence
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • 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 11, 2010 the kitten became symptomatic. On August 12, 2010 the kitten became lethargic, weak, and had urinary and fecal incontinence, so later that day the owner bathed the kitten twice with an unknown flea and tick shampoo. On August 13, 2010 the owner found the kitten dead. Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS assistant relayed the APSS veterinarian's recommendations to contact his regular veterinarian to have a necropsy done, call back with questions, and call the manufacturer for reimbursement questions. The owner declined the necropsy as the pet had already been buried.


To be determined by Registrant

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

Death

19. Provide supplemental information here

A follow up was not performed, because additional information was not expected. This product was not used according to label directions. According to the specialsiss at APSS, use of the product was not related to the clinical signs.