Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4596

2. Registrant Information.

Registrant Reference Number: 170103330

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.

20-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

15-JUN-17

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. 2724-485-270

Product Name: Adams Plus Flea and Tick Shampoo with Precor for Dogs and Puppies

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .1 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 1.5 %
  • PYRETHRINS
    • Guarantee/concentration .15 %

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-139-89459

Product Name: Adams Plus Flea and Tick Collar for Large Dogs and Puppies

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration 1.02 %
  • TETRACHLORVINPHOS
    • Guarantee/concentration 14.55 %

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7. b) Type of formulation.

Liquid

Other (specify)

Collar

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 June 11, 2017 the owner bathed the dog with the shampoo to treat a condition. On June 13, 2017 the owner applied the collar to the dog to treat a 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

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 )

120.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting
  • Symptom - Bloody vomit

• Nervous and Muscular Systems
  • Symptom - Depression

• 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 June 15, 2017 the dog developed symptoms and the owner removed the collar. On June 16, 2017 the dog had bloody vomit and became depressed. That evening, the owner tried to contact a veterinarian but they were closed and the dog died that night. On June 20, 2017 an employee from the store where the product was purchased contacted the Animal Product Safety Service (APSS). On June 21, 2017 an APSS assistant contacted the owner and the APSS veterinarian stated that tetrachlorvinphos in the collar is an organophosphate (OP) and is often found in flea collars for dogs and cats. The APSS veterinarian also stated that dermal absorption is low in dogs and cats (less than 20 percent for collars and dips), but all species can have some oral absorption if ingested. The APSS veterinarian further stated that for an OP, it has a wide margin of safety and is generally well tolerated. The APSS veterinarian also stated that OP's can cause salivation, lacrimation, urination, defecation, dyspnea, and emesis, with bradycardia, and nicotinic receptor signs of tremors, ataxia, weakness and seizures. Finally, the APSS veterinarian stated that tetrachlorvinphos, even in large exposures, will primarily be a concern for hypersalivation, vomiting, diarrhea, and mild lethargy. The APSS veterinarian also stated that death would not occur from this exposures. The APSS assistant recommended the owner call 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 substances were not considered to be related to causing the clinical situation. A necropsy was not available as the dog had already been buried.