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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1022

2. Registrant Information.

Registrant Reference Number: 160194568

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.

30-DEC-16

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

30-DEC-16

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. 2724-813-270

Product Name: Adams Flea and Tick Spot On for Cats 5 lbs and Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 December 28, 2016 the owner applied the product onto the pet 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

30.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • 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 December 30, 2016 the owner noticed the cat was lethargic and had a behavior change (did not use the litter box). Later that day, the owner found the cat dead (when she came home from work). The owner then contacted the Animal Product Safety Service (APSS) as she believes the product killed her cat and wants the company to know. The APSS veterinarian stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers and if ingested there could be hypersalivation and nausea. The APSS veterinarian also stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs. The owner disagreed with the APSS veterinarian and wanted the company to know as she believes the product should be taken off the market. The APSS veterinarian referred the owner to the manufacturer (to discuss product questions) and let the owner know the company would receive a copy of the medical record. The APSS veterinarian also recommended calling back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian called the owner back on December 30, 2016 and offered a necropsy. The owner declined as the cat's body had already been buried and she was not interested in a necropsy. The APSS veterinarian recommended calling back with questions.