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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0031

2. Registrant Information.

Registrant Reference Number: 090135697

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.

07-DEC-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-DEC-09

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: drop

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 December 6, 2009 the owner inappropriately applied 1 drop of the product onto the cat before she read the product label.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

15

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Irritated skin
    • Specify - Rubbing Application Site
  • General
    • Symptom - Hissing
    • Symptom - Pale mucous membrane colour
  • Eye
    • Symptom - Pupil dilation
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Specify - Paw Shaking

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.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

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 December 7, 2009 the owner bathed the application area with an oatmeal shampoo. The APSS veterinarian stated cats do not tolerate permethrin, and there are individual variations in sensitivity. She also stated signs range from mild dermal hypersensitivity to seizures, and signs can develop from almost immediately up to 72 hours post-exposure. The APSS technician relayed the APSS veterinarian's recommendations to monitor the cat at home for central nervous system (CNS) signs, bathe the cat with liquid dish washing detergent, provide thermoregulation by keeping the cat warm, and call back with questions. In the evening of December 7, the owner call the APSS to update the case. The owner stated the cat had been having mydriasis, which then would return to normal, all day, and the cat's rear paws were shaking. The owner also stated the cat's rubbing at the application site, hissing, and agitation had all resolved. The APSS veterinarian recommended bathing the cat with LDWD, taking him to the veterinarian if any CNS signs developed, having the veterinarian call for information, monitoring the cat closely for any increased twitching, and calling back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On December 9, 2009 the owner returned the follow up call from the APSS technician to update the case. She stated the cat slowly improved after the LDWD bath, and on the morning of December 9, the cat had fully recovered. This product was not used according to label directions: Do not use on cats.