Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7182

2. Registrant Information.

Registrant Reference Number: 120160543

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.

18-NOV-12

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

17-NOV-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 Flea and Tick Spray For Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
  • 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 November 17, 2012 the owner bathed the dog with a flea and tick shampoo and then sprayed the dog with a flea and tick spray. The owner thought that the dog might have licked each product as well. Spray was used to treat lice not as per label use.

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

Dog / Chien

3. Breed

Bichon Frise Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

21.0

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Nervous and Muscular Systems
  • Symptom - Trembling

• Gastrointestinal System
  • Symptom - Bloody diarrhea

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 November 17, 2012 the owner noticed that the dog was vomiting; he vomited about 5 times in the evening and once overnight. The vomiting had ended by the next morning, November 18, 2012; however, at that time to owner also noticed that the dog was lethargic, anorexic, and trembling. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the concern with both products was for dermal hypersensitivity and mild gastrointestinal (GI) upset with an oral exposure. The APSS assistant recommended that the owner protect the dog's gastrointestinal (GI) tract by giving 5 milligrams (mg) of famotidine for 2 days, monitor the dog at for continuing vomiting and for worsening or continued lethargy, take the dog to the veterinarian if signs persisted or worsened, and call back with questions.

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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 both products were considered to have a doubtful likelihood of causing the clinical situation. On November 20, 2012 an APSS assistant called the owner to update the case. The owner stated that he did monitor the dog at home and that the dog's signs continued. The owner also stated that on the morning of November 19, 2012 the dog had developed bloody diarrhea. Later that day, the owner took the dog to the veterinarian, where the dog was treated with famotidine, sucralfate, and metronidazole. The dog's treatment is ongoing. Owner treating for pest not on label.