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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-4867

2. Registrant Information.

Registrant Reference Number: 2021-CA-000083

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: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

06-MAY-21

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-MAY-21

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. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot with Smart Shield Flea and Tick Control for Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 2.9 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

9.98

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Swelling
  • Skin
    • Symptom - Red skin
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Hiding
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • General
    • Symptom - Abnormal behaviour
    • Specify - Looking at back
  • Skin
    • Symptom - Lesion

12. How long did the symptoms last?

Unknown / Inconnu

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

No

14. a) Was the animal hospitalized?

No

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 01 May 2021, the animal owner applied the applied the product topically to her dog. Immediately after application, the skin around the dog developed symptoms; this lasted 1-2 hours and then resolved. On 02 May 2021, the dog developed symptoms. The animal owner bathed the dog on 05 May 2021 twice with a human body wash product. On 05 May 2021, diphenhydramine was administered by the animal owner. Temporary improvement of symptoms was noted by the animal owner following diphenhydramine administration. Bathing with a degreasing dish soap and application of cool compresses was discussed with the animal owner. On a follow up call, animal owner noted no improvement in the dog after bathing with the degreasing dish soap. On 07 May 2021, the dog developed two sores (lesions) on the side of the dogs back but not near an application site. Dog was not seen self-traumatizing the area of the sores. Veterinary care was recommended. No further information is expected.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.