Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6915

2. Registrant Information.

Registrant Reference Number: 180096451

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.

07-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-JUN-18

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. 31446      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Power Band Plus Dual Action Flea And Tick Collar For Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • TETRACHLORVINPHOS

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 June 6, 2018, the owner applied the collar to the cat as 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

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 )

0.67

7. Weight (provide a range if necessary )

5.5

lbs

8. Route(s) of exposure

Skin

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

• Respiratory System
  • Symptom - Wheezing

12. How long did the symptoms last?

>2 hrs <=8 hrs / > 2 h < = 8 h

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

Within an hour after the product was applied on June 6, 2018, the cat had an isolated event of wheezing (or making a huffing sound while breathing). About another hour later, the cat started wheezing again. The owner then removed the collar and washed the area with liquid hand soap. A few hours later, in the early morning on June 7, 2018, the cat's wheezing resolved. In the afternoon on June 7, 2018, the owner contacted the Animal Product Safety Service (APSS) to obtain information. The APSS veterinarian stated that the risk is for paresthesia on the skin or mouth if chewing on the collar occurs and that the smell can be irritating to some animals. The APSS technician recommended the owner monitor at home, take the cat to a veterinarian and have the veterinarian call for information (if signs develop), and to call back with questions.

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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

Signs were expected to be mild and self-limiting.