Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0130

2. Registrant Information.

Registrant Reference Number: 120128387

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.

12-SEP-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-SEP-12

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. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • PIPERONYL BUTOXIDE
  • PYRETHRINS

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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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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 August 22, 2012 the owner sprayed the cat with the flea and tick spray product to treat for fleas. On August 29, 2012 the owner still noticed fleas on the cat, so the owner applied the spot on product to the cat. On September 11, 2012 the owner bathed the cat with the flea and tick shampoo product.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Ear
  • Symptom - Other
  • Specify - Ear Twitching

• Nervous and Muscular Systems
  • Symptom - Tail twitching
  • Symptom - Agitation

• General
  • Symptom - Pale mucous membrane colour

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

Not recovered / Non rétabli

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 September 12, 2012 the owner noticed that the cat was symptomatic. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that with the flea and tick spray product, dermal irritation was possible and if some were ingested, mild gastrointestinal (GI) upset and hypersalivation were possible. The APSS veterinarian also stated that paresthesia was also possible, and that central nervous system (CNS) depression was possible if the cat was saturated and the product was alcohol based. Regarding the spot on product, the APSS veterinarian said that dermal irritation was possible and that if the product were ingested, mild GI upset and hypersalivation would be possible. For both of the products, the APSS veterinarian said that signs would have been expected to have begun closer to the exposure time. The APSS veterinarian stated that the flea and tick spay product could cause dermal irritation and that, if ingested, mild GI signs are possible. The APSS veterinarian also said that paresthesia was possible, but unlikely with a shampoo and low concentration pyrethrins. The APSS assistant recommended that the owner monitor the cat's mucous membrane color, which she did during the consultation. The owner observed that the cat's mucous membranes were pale. The APSS assistant also recommended that the owner rinse the cat's coat and skin with water and consult with a veterinarian about flea prevention. The call was disconnected before the APSS assistant could recommend that the owner take the cat to the veterinarian for evaluation and to determine if the cat was anemic.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the flea and tick shampoo product, the flea and tick spray product, and the spot on product were considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian stated that a flea infestation was considered to have a medium likelihood of causing the clinical situation. On September 14, 2012 an APSS assistant contacted the owner to update the case. The owner stated that the cat remained symptomatic and was still suffering from a flea infestation.