Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7524

2. Registrant Information.

Registrant Reference Number: 160126854

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.

25-AUG-16

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

6. Date incident was first observed.

24-AUG-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-491-270

Product Name: Adams Plus Breakaway Flea and Tick Collar for Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 2.1 %
  • PROPOXUR
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: count

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 August 14, 2016 the owner put the collar onto the cat to treat for ticks.

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 Shorthair

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 )

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

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Skittish

• Gastrointestinal System
  • Symptom - Vomiting
  • Symptom - Diarrhea

• Respiratory System
  • Symptom - Dyspnea

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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 August 24, 2016 the cat became skittish. On August 25, the cat developed vomiting, diarrhea, and dyspnea. Shortly after the owner took the cat to the veterinarian where fluid therapy, atropine, doxapram, diphehydramine, and oxygen were given. Later that afternoon the cat died, so the owner took the cat home and buried the body. Later that evening the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated propoxur is a carbamate insecticide. The APSS veterinarian also stated typically carbamate toxicity can result in salivation, defecation, dyspnea, emesis (SLUDDE) signs, bradycardia, and possible nicotonic signs including tremors and seizures. The APSS veterinarian finally stated the most common signs reported in cats in Animal Poison Control Center (APCC) database include hypersalivation, agitation, hyperesthesia and gastrointestinal (GI) upset. The APSS veterinarian recommended a necropsy and stressed the importance of time in a situation like this. If the owner wanted to pursue a necropsy, the body would need to be taken to the veterinary clinic and have the veterinarian call for information for necropsy submission. The owner asked whether the attending veterinarian could collect samples and send them in or if she could get the body back. The APSS veterinarian stated we can look into it, but that is not typically how it is handled. The APSS veterinarian referred the owner to the manufacturer (for questions relating to product and reimbursement).

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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 not related likelihood of causing the clinical situation. On August 29, 2016 an APSS technician called the attending veterinary clinic to discuss necropsy. A message was left for the veterinarian, but according to the receptionist it didn't appear the owner ever brought the cat's body into the clinic.