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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-6109

2. Registrant Information.

Registrant Reference Number: 070053643

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1g 5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

29-MAY-07

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

24-MAY-07

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.

Product Name: Bio Spot On Flea And Tick Control For Cats and Kittens Under 5 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.034

Units: oz (fl) / oz (liquide)

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 May 19, 2007, at 12:00 pm, CDT, the owner applied this product to her 1 year old, male neutered, domestic longhair cat. The product was applied dermally to the animal. The owner was applying the product to treat a flea infestation.

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 Longhair Cat

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Dizziness
    • Symptom - Disorientation
  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Renal failure
  • General
    • Symptom - Death

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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 May 24, 2007 at 12:00 pm, CDT, the owner noted that the animal was acting lethargic. On May 20, 2007, at 12:00 pm, CDT the owner reported that the cat was dizzy and disoriented. On May 29, 2007 at 12:12 pm, CDT, the owner called to report the exposure and that the cat had been seen by a veterinarian and was diagnosed with renal failure. The APSS CVT, recommended to have the veterinarian call us with any questions. The APSS CVT, noted that with this exposure, in some sensitive animals, we would expect to see dermal hypersensitivity and mild tremors develop within 24 hours. Signs should be self-limiting and the APSS CVT noted she would not expect the animal to develop signs > 10 days from the time of exposure.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Signs developed 10 days after product application. Diagnosed with renal failure. APSS stated the product was considered to have not related likelihood of causing clinical situation. No necropsy was performed due to the fact that APSS unable to contact the owner.