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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0855

2. Registrant Information.

Registrant Reference Number: 100145423

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.

09-NOV-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

05-NOV-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. 2724-504-270

Product Name: Bio Spot Spot On Flea and Tick Control for Cats 5 Lbs and Over

  • 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.

.061

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 November 1, 2010 the owner applied 1/3 of the product's applicator 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 Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

8

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

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Anorexia
  • 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 November 4, 2010 the owner bathed the cat with medicated shampoo with tea tree oil. Between November 4 and November 6, 2010 the owner noticed the cat became progressively more symptomatic. On November 7, 2010 the owner noticed the cat was anorexic and had diarrhea. On November 9, 2010 the owner contacted the Animal Product Safety Service (APSS). The APSS recommended taking the cat to the veterinarian and having the veterinarian call for information. The owner stated that he could not take the cat to the veterinarian due to financial reasons. The APSS veterinarian then recommended bathing the cat with liquid dish washing detergent and toweling the cat dry.


To be determined by Registrant

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

Death

19. Provide supplemental information here

According to the APSS veterinarian dermal signs are sometimes noted with this product but they occur within 24 hours of exposure. Since the clinical signs did not occur until 5 days later, another cause is suspected. On November 13, 2010 an APSS assistant called the owner to follow up the case. The owner stated that he didn't end up bathing the cat as the cat was too weak and the cat died on November 10, 2010. This product was not used according to label directions: inappropriate dose.