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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7298

2. Registrant Information.

Registrant Reference Number: 130144311

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.

15-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

10-OCT-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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control For Cats And Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Units: mL

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 10, 2013 the owner applied the product to the cat to treat for fleas.

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

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
  • Ear
    • Symptom - Other
    • Specify - Ear Twitching
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Specify - Inability to Stand
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Tongue Protrusion
  • Nervous and Muscular Systems
    • Symptom - Trembling
  • General
    • Symptom - Weakness
    • Symptom - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

Not recovered / Non 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 October 10, 2013 the owner noticed that the cat was acting uncomfortable, having fasciculations, and twitching her ears. On October 13, 2013 the owner noticed that those signs had become severe and that the cat was unable to stand, experienced tongue protrusion, and was trembling. Later that day the owner took the cat to the veterinarian, where 2 milligrams (mg) of Diazepam was giving twice daily, subcutaneous fluid therapy was given, and symptomatic and supportive care were given, including an injection of a muscle relaxant. The owner noticed that on October 15, 2013 the cat no longer had fasciculations, ear twitching, an inability to stand, tongue protrusion, or trembling. That day, the owner noticed that the cat was still acting uncomfortable and was weak. Later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that systemic effects would not be expected, and that an exposure to Permethrin would need to be ruled out. The APSS technician recommended that the owner have her regular veterinarian call for information and discuss having Permethrin hair testing done.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation and that Permethrin was considered to have a medium likelihood of causing the clinical situation. On October 21, 2013 an APSS technician called the owner to update the case. The owner stated that on October 16, 2013 the cat was no longer acting uncomfortable and weak, but the cat was observed to be lethargic at that time. The cat was still lethargic at the time of the follow-up call. As the owner's regular veterinarian did not contact the APSS to discuss the case, Permethrin hair testing is not available.