Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-6664

2. Registrant Information.

Registrant Reference Number: 150126872

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.

14-SEP-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-SEP-15

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. 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 September 12, 2015 the owner inappropriately split the vial between the two cats in the household.

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.58

7. Weight (provide a range if necessary )

6.5

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

• General
  • Symptom - Hiding

• Gastrointestinal System
  • Symptom - Drooling

• Nervous and Muscular Systems
  • Symptom - Seizure

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

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 13, 2015 the cat developed symptoms. The owner then took the cat to the veterinarian, where fluid therapy, diazepam, methocarbamol, and phenobarbitol was given, and the cat was bathed. The pet continued to seizure after the treatments, so the cat was euthanized. On September 14, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated methoprene is an insect growth regulator (IGR) with a wide margin of safety in dogs and cats and significant central nervous system (CNS) signs are not expected. The APSS veterinarian discussed the case with the owner and if any dogs had been treated in the household recently. The APSS veterinarian recommended a necropsy (the owner reported she left the cat's body with the clinic to be cremated). The owner stated she may check with the clinic to see if the cremation had already been done.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 16, 2015 an APSS technician spoke with the owner regarding the cat's body and the necropsy and hair testing. The APSS technician called the attending veterinary clinic to discuss the cat's body. The attending veterinary staff member stated the cat's body had been picked up by the cremation service and they had already closed, but she would leave a message with them. Later that evening, the attending veterinarian called the APSS to discuss whether the company covers the expenses for a necropsy. On September 17, 2015 the APSS technician called the attending veterinary clinic who stated that the cremation facility no longer had the cat's remains, so a necropsy was not possible. Product was applied off label-wrong dose.