Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2817

2. Registrant Information.

Registrant Reference Number: 170079733

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.

15-MAY-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

10-MAY-17

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. 31984      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac InfeStop Topical Solution For Cats Over 4 kg

• Active Ingredient(s)
  • IMIDACLOPRID

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

Units: mL

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 May 8, 2017 the owner applied the product to the cat for prevention.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.5

7. Weight (provide a range if necessary )

4.9

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Symptom - Seizure

• Gastrointestinal System
  • Symptom - Salivating excessively

• Nervous and Muscular Systems
  • Symptom - Disorientation
  • Symptom - Ataxia

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 May 10th 2017, two day after the product was applied, the owner began to observe symptoms. On May 12, 2017 the owner took the cat to their regular veterinarian who gave the cat a bath twice (using liquid dish washing detergent (LDWD), gave diazepam, ran a chemistry profile (all normal), gave fluids (subcutaneously twice, dispensed fluids for owner to administer), gave methocarbamol (by mouth (PO), and gave phenobarbital. The regular veterinarian stated no tremors were perceived on examination. On May 15, 2017, the regular veterinarian contacted the Animal Product Safety Service (APSS) on behalf of the owner. The APSS veterinarian stated that imidacloprid is an insecticidal agent that has a wide margin of safety in mammals. The APSS veterinarian also stated that it kills insects by binding to the nicotinic acetylcholine receptors in the insect nervous tissue, which are much more prevalent than in mammals. The APSS veterinarian stated that signs were not consistent with the product used and that the signs do not sound like permethrin, either. The APSS veterinarian recommended referral to the manufacturer.

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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 May 23, 2017 an APSS technician called to follow up the case. The regular veterinarian stated that on May 19, 2017 the cat was euthanized. On May 24, 2017 an APSS technician contacted the regular veterinarian regarding a necropsy. Because the cat was frozen for five days, a necropsy would be unproductive. The APSS technician recommended a permethrin hair test. At the time of this report, the results are still pending.