Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0955

2. Registrant Information.

Registrant Reference Number: 110102624

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.

09-AUG-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-AUG-11

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)

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PMRA Registration No. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar For Cats

• Active Ingredient(s)
  • PROPOXUR

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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

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PMRA Registration No. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 July 26, 2011 the owner placed a flea and tick collar on the cat to treat for fleas. The owner removed the collar on August 2, 2011, and later that afternoon she applied 1.0 mL of the spot on product to the cat. On August 7, 2011 the owner bathed the cat with a flea and tick shampoo.

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

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

19.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Drooling

• Skin
  • Symptom - Lesion
  • Specify - Scab

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 2, 2011, about 1 week after placing the flea and tick collar. The owner removed the collar after noticing the alopecia. Later that afternoon, the owner applied a spot on flea control product to the cat, and the cat began to drool immediately. Per the owner, this was an isolated event. On August 7, 2011 the owner noticed a scab on the cat's neck where the collar had been, and there were other scabs covering the cat's entire body. Per the owner, the scabs were healing. That evening, the owner bathed the cat in the flea and tick shampoo, and half an hour later she applied a Polysporin ointment to the cat. On August 9, 2011, the owner noticed the cat no longer had alopecia. Shortly after, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that with the use of the flea and tick collar, dermal reactions could occasionally occur and were expected to be self-limiting. The APSS veterinarian also stated that the use of the spot on flea control product could cause dermal reactions, but that serious problems were not expected. The APSS veterinarian stated that shampoos are generally safe and that allergic reactions are possible. The APSS technician recommended that the owner take the cat to the veterinarian and have the veterinarian call for information.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the flea and tick shampoo was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.