Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-1428

2. Registrant Information.

Registrant Reference Number: 150155549

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.

10-NOV-15

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

08-NOV-15

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-803-270

Product Name: Adams Flea And Tick Spray for Dogs and Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • ETOFENPROX
    • Guarantee/concentration .25 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .75 %

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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 November 8, 2015 the owner sprayed about 6 pumps of the product onto the cat as treatment.

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

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Drooling

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Bloody stool

• General
  • 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 November 8, 2015 the cat developed hypersalivation. On November 9, 2015 the cat developed lethargy. That evening the owner bathed the cat and noticed the cat had bloody feces. Overnight the owner found the cat dead. On November 10, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated bloody diarrhea and death are not usually attributable to exposure to these ingredients so the cat's death may be due to other causes. The APSS veterinarian also stated etofenprox is in the pyrethroid family, and is safe to use on cats and dogs and it does not result in tremors or seizure activity that can be seen from other pyrethroids, since it is structurally different. The APSS veterinarian stated oral exposures often result in hypersalivation, nausea, and possibly hiding because of the taste; some animals will hypersalivate just from the odor of the product. The APSS veterinarian additionally stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are that if ingested there could be hypersalivation and nausea. The APSS veterinarian finally stated piperonyl butoxide and is a synergist to enhance the efficacy of the ingredients. The APSS veterinarian provided information. A short time later the APSS veterinarian called the owner to inquire where the product was purchased from and what she did with the cat's remains. The owner stated that she had purchased the product from (company name) and her father had taken the cat's body to be buried. The APSS veterinarian stated if the cat's body was still viable, she could take the cat's body to her local veterinary clinic for shipment for necropsy. The APSS veterinarian recommended having the veterinarian call for information and a necropsy. The owner stated she would call her father and see if the cat's body had been buried or not.

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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. A necropsy was not available as the owner did not call the APSS back to discuss.