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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2013-7277

2. Registrant Information.

Registrant Reference Number: 130131438

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.

18-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

14-SEP-13

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • 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 September 14, 2013 the owner sprayed the cat with the product to treat for 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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
  • Nervous and Muscular Systems
    • Symptom - Trembling
    • Symptom - Muscle tremors
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 September 14, 2013 the cat had an isolated episode of drooling and was trembling and having tremors shortly after being exposed to the product. Later that afternoon the owner took the cat to the veterinarian, where the cat was given symptomatic care consisting of an intravenous (IV) relaxant, something being applied to the cat's skin to remove the product, and a tablet to help with the shaking. The owner took the cat home from the clinic that day. On September 15, 2013 the owner noticed that the cat was anorexic and adipsic. On September 16, 2013 the owner took the cat back to her regular veterinarian, where the cat received symptomatic care consisting of an injection to help hydrate her and an appetite stimulant and antacids. On the morning of September 17, 2013 the cat was no longer anorexic and adipsic. Later that day the cat had fully recovered. On September 18, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that labeled use of the agent is considered safe, and some cats will experience a transient drooling effect following topical application of the product. The APSS assistant referred the owner to the product's manufacturer.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Status udpate: RE Incident report clarification - status update - 2013-7277 (name) to Marc A Leger 2014 02 03 03:55 PM