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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3816

2. Registrant Information.

Registrant Reference Number: 100067814

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.

29-MAY-10

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

6. Date incident was first observed.

29-MAY-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 and Kittens Under 5 Lb

  • 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 28, 2010 the owner gave a tablet orally to treat for fleas, applied a flea and tick dip, and then applied the wrong size dose of product to 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

Medical Professional

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 )

1

7. Weight (provide a range if necessary )

6.9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Eye
    • Symptom - Blindness (temporary)
  • Gastrointestinal System
    • Symptom - Drooling
  • Eye
    • Symptom - Pupil dilation
  • Skin
    • Symptom - Hyperesthesia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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 May 29, 2010 the owner took the cat to the veterinarian where fluid therapy was given. Shortly after, the attending veterinarian contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated cats tend to tolerate etofenprox much better than permethrin. The APSS veterinarian recommended obtaining additional information on other possible exposures, having a diagnostic evaluation completed, supportive care, and calling back with questions.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Later on May 29, 2010 the attending veterinarian called the APSS back to update the case. The attending veterinarian stated the owner is adamant there is no risk for marijuana or ivermectin, and the house is 30 years old, so probably no risk of lead paint. The APSS veterinarian recommended trying to find out if the cat had been exposed to other medications. The APSS veterinarian recommended bathing the cat with liquid dish washing detergent, administering diazepam and methocarbamol, and monitoring the cat's blood pressure. On June 2, 2010 an APSS technician called the clinic to update an update on the case. The attending veterinarian stated the cat had died the evening of May 29, 2010. The APSS technician recommended a necropsy. Shortly after, a veterinary technician from the attending clinic called the APSS back and stated that the owner had opted not to do the necropsy, as the pet had been buried.