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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-4263

2. Registrant Information.

Registrant Reference Number: 2020-US-006179

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-APR-20

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

02-APR-20

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.       PMRA Submission No.       EPA Registration No. 2724-485-270

Product Name: Adams Plus Flea and Tick Shampoo w Precor For Cats, Kittens, Dogs, Pup

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.88 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

7. b) Type of formulation.

Liquid

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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Siberian

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

4.082

kg

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 / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - sedation
    • Symptom - Muscle twitching
  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Hiding
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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 2-Apr-2020 the cat was bathed with the product. The cat was noted to be very sedate afterwards. The cat was dried off and hid briefly. Within 2-3 minutes the cat developed symptoms. Cat was brought to a veterinarian where no treatments were performed, and the cat died a few minutes later. Necropsy was not performed. No further information is is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: This shampoo has a wide margin of safety and the severity of the clinical signs noted in this case is not expected, however individual sensitivities may exist. Labored breathing could occur following aspiration or stress during the bathing process but would not be expected directly due to this product. Other causes for this catżżżżżżs clinical signs and death should be considered including exposure to other products, underlying cardiac disease, underlying respiratory disease, and stress compounding underlying disease. Necropsy may have provided additional information but was not pursued by the animal owner. 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.