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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5570

2. Registrant Information.

Registrant Reference Number: 100120160

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.

13-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: RHODE ISLAND

6. Date incident was first observed.

13-SEP-10

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. 2724-497-270

Product Name: Bio Spot Spot On Flea and Tick Control for Dogs Medium Size 31-60 Lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3 %
    • PERMETHRIN
      • Guarantee/concentration 45 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.25

Other Units: vial

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 13, 2010 the owner inappropriately applied 1/4 vial of the agent onto the cat.

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 )

2

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Respiratory System
    • Symptom - Panting
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 September 13, 2010 the cat became symptomatic. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended taking the cat to the veterinarian and having the veterinarian call for information. The APSS veterinarian also discussed with the owner that the use of this product on cats is contraindicated.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On September 15, 2010 an APSS assistant called the owner to follow up the case. The owner stated the cat died after the APSS consultation and she did not take the cat into the clinic. The owner also stated that the cat's body had been buried and a necropsy was not possible at this time. This product was not used according to label directions: Do not use on cats.