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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5176

2. Registrant Information.

Registrant Reference Number: 160099870

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.

09-JUL-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-JUL-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)

PMRA Registration No. 19209      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Shampoo

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

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 July 6, 2016 the owner used the product on the dog to treat fleas.

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

Canine Domestic Unspecified

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

80.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Anorexia
  • 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?

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 July 6, 2016 the dog was taken to the regular veterinarian for vaccination boosters. On July 7, 2016 the dog developed symptoms. The owner then took the dog to veterinarian, where a chemistry profile and complete blood count were done. The owner stated the veterinarian stated the dog was drunk and no treatments were administered. On July 9, 2016 the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated the active ingredients are pyrethroids; with ingestion expect oral paresthesia. The APSS veterinarian also stated common clinical signs may include gagging, retching, lip licking, increased swallowing, and vomiting from the tingling/burning sensation in the mouth and throat. The APSS veterinarian further stated these signs often occur right after exposure, and are usually self-limiting. The APSS veterinarian finally stated central nervous system (CNS) signs are not expected. The APSS assistant recommended having the veterinarian call for information, calling back with questions, and taking the dog to the veterinarian.


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 July 10, 2016 the owner called the APSS back. The owner stated the dog is drinking, eating very little, and is still markedly ataxic. He took the dog for a swim on the morning of July 8, 2016 and was able to swim, coordination was good until she got out and tried to walk again. The owner stated he was concerned that the dog was fine when bathed, but could not walk the next morning. The vaccinations given were for hepatitis, leptospirosis (lepto), parvovirus, parainfluenza, and distemper. The APSS veterinarian recommended taking the dog to the veterinarian and having the veterinarian call for information. On July 13, 2016 the owner called the APSS back and stated a few hours ago he had found the dog dead. The owner stated the dog had shown no improvement and would not eat anything so on July 10, 2016 the owner took the dog back to the veterinarian where symptomatic care (antibiotics and prednisone) was given. The owner also stated he believes the dog was injected with a "euthanasia serum". The APSS veterinarian recommended a necropsy. The APSS veterinarian stated that vestibular syndrome was considered to have an unknown likelihood of causing the clinical situation. A necropsy is not possible as the tissues would not be viable.