Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5169

2. Registrant Information.

Registrant Reference Number: 160076661

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.

29-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW HAMPSHIRE

6. Date incident was first observed.

29-MAY-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. 1021-2684-89459

Product Name: Adams Flea and Tick Dip for Dogs and Cats

• Active Ingredient(s)
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 3 %
  • PYRETHRINS
    • Guarantee/concentration .3 %

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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 May 28, 2016 the owner inappropriately used the flea dip on the ferret and also gave a kitten dewormer.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Other / Autre

specify Ferret

3. Breed

Domestic Ferret

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

2.3

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

• Nervous and Muscular Systems
  • Symptom - Collapse
  • Symptom - Unresponsive

• General
  • Symptom - Hypothermia

• Cardiovascular System
  • Symptom - Bradycardia

• General
  • Symptom - Pale mucous membrane colour
  • 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 May 29, 2016 the ferret collapsed and had white mucous membranes. A short time later the ferret became unresponsive and while at the veterinary clinic had hypothermia, with a temperature measured at 97.5 degrees Fahrenheit (deg F). The ferret also had bradycardia with a heart rate measured at 110.0 beats per minute (bpm) and respirations measured at 30.0 respirations per minute (rpm). The attending emergency veterinarian gave karo syrup as he suspected hypoglycemia and the ferret became somewhat responsive. The emergency veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian recommended a diagnostic evaluation, symptomatic care, and calling back with questions.

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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 Adams dip was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian stated that the dewormer was considered to have a doubtful likelihood of causing the clinical situation. On June 6, 2016 the attending veterinary clinic's office manager called the APSS to request a case summary. She stated that the ferret had died on May 29, 2016 after the consultation with the APSS and no necropsy was performed. On June 10, 2016 the owner called the APSS with questions about the case and possible causes of the symptoms. The APSS veterinarian reviewed the case with the owner and stated the insecticides/dewormers didn't cause the ferret to die. The APSS veterinarian stated it could have been neoplasia or heart disease and ferrets can get infections and cancer and without a necropsy the reason will never be known. This was an off label used of product.