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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1015

2. Registrant Information.

Registrant Reference Number: 160166436

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-NOV-16

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH DAKOTA

6. Date incident was first observed.

24-OCT-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. 2724-797-89459

Product Name: Bio Spot Active Care Flea and Tick Spray for Cats and Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • ETOFENPROX
      • Guarantee/concentration .5 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.75 %

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).

On October 23, 2016 the product was applied to the cat to treat condition.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 October 24, 2016 the cat developed hypersalivation. On October 27, 2016 the cat developed lethargy and anorexia. On October 28, 2016 the owner took the cat to the veterinarian (unknown whether any treatment was given). On October 29, 2016 the cat died at the clinic. The APSS veterinarian stated contact hypersensitivity may occur as with any topical exposure. The APSS veterinarian stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation (paresthesia) that may be associated with this type of product. The APSS veterinarian further stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS veterinarian finally stated if alcohol based, low risk for central nervous system (CNS) depression/ataxia. The APSS veterinarian recommended a necropsy, but the cat's body had already been cremated.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Later on November 7, 2016 the owner's daughter called the APSS back to further discuss the case and asked about medical bill reimbursement. The APSS veterinarian discussed that we would not expect the product use to result in death and recommended that the attending veterinarian call for information (to discuss). The APSS veterinarian referred the owner's daughter back to the manufacturer (to discuss reimbursement).