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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0733

2. Registrant Information.

Registrant Reference Number: 170178994

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.

13-OCT-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

13-OCT-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-84-89459

Product Name: Zodiac Flea And Tick Collar For Small Dogs 7 Months Protection

  • Active Ingredient(s)
    • TETRACHLORVINPHOS
      • Guarantee/concentration 14.55 %

7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.17

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Death
    • Symptom - Discomfort
    • Specify - uncomfortable

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

Fifteen minutes after applying the collar on October 13, 2017, the owner removed it as the dog seemed uncomfortable. About twenty minutes after the collar was removed, the dog had a seizure and developed hypersalivation. An hour later, the dog had another seizure. Shortly after, the owner bathed the dog and gave milk. Within minutes, the dog had another seizure so the owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that tetrachlorvinphos is an organophosphate (OP) with a very wide margin of safety and that it is used in flea collars for dogs and cats and feed through larvicides for horses. The APSS veterinarian also stated that it is very rare to see (SLUDDE) or nicotinic signs with tetrachlorvinphos. The APSS assistant recommended the owner take the animal to a veterinarian, have the veterinarian call for information, and to call back with questions.


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. On October 15, 2017, an APSS assistant called the owner to follow up on the case. The owner stated that the dog seized for fifteen hours and passed away on October 14, 2017. A necropsy was offered but the owner declined.