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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6035

2. Registrant Information.

Registrant Reference Number: 190011907

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.

21-JAN-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-JAN-19

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)

PMRA Registration No. 31446      PMRA Submission No.       EPA Registration No.

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

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

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 January 14, 2019, the owner applied the collar to the cat to treat a condition.

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 Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Specify - Application Site Alopecia
    • Symptom - Burns (superficial)
    • Specify - Application Site Burn
  • General
    • Symptom - Hiding

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

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

On January 18, 2019, the cat developed symptoms. The owner then removed the collar. On January 21, 2019, the cats symptoms disipated. The owner then contacted the Animal Product Safety Service (APSS). The APSS assistant stated that the risk is for dermal sensitivity in some pets, especially in outdoor pets when the fur may become wet. The APSS assistant recommended the owner monitor at home, consult a veterinarian (about alternate flea control), monitor for dermatological signs (if not improving, call back), and to call back with questions.


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 tp be mild and self-limiting.