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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-5816

2. Registrant Information.

Registrant Reference Number: 070080012

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

Address: 100 Stone Rd. 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.

30-JUL-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

30-JUL-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. 17189      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Powder

  • Active Ingredient(s)
    • CARBARYL

PMRA Registration No. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 July 29, 2007, at 10:00 am, CDT, the owner applied both of the products to her cat. The product was applied dermally.

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 )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • General
    • Symptom - Death

12. How long did the symptoms last?

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

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 July 30, 2007 at 2:30 am, CDT, the owner noticed that the cat had begun to seize. The owner took the cat to the veterinarian. The veterinarian had already treated the cat's seizures with diazepam. The veterinarian spoke to the Animal Product Safety Service (APSS) veterinarian who recommended that the veterinarian treat the seizures with methocarbamol, monitor the cat's body temperature, provide symptomatic and supportive care, as well as, permethrin hair testing. The veterinarian called the APSS veterinarian back at 11:14 am, on July 30, 2007 to report that the cat had some response to the methocarbamol, but not an adequate response. The veterinarian then treated the seizures with propofol. The cat died on July 30.


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 recommended that a necropsy be done on the cat and the owner declined. The APSS veterinarian stated that these signs are suspected from a permethrin product. The product was not used according to label directions. The veterinarian who treated the cat reported to APSS that a product labeled for use on dogs only was applied on the cat.

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 )

5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Ataxia
  • Eye
    • Symptom - Permanent change in vision
    • Specify - blindness

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?

3

Day(s) / Jour(s)

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

The veterinarian treated the cat's seizures with diazepam. The veterinarian spoke to the Animal Product Safety Service (APSS) veterinarian who recommended that the veterinarian treat the seizures with methocarbamol, monitor the cat's body temperature, provide symptomatic and supportive care, as well as; permethrin hair testing. The veterinarian called the APSS veterinarian back at 11:14 am, on July 30, 2007 to report that the cat had some response to the methocarbamol, but not an adequate response. The veterinarian then treated the seizures with propofol.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The veterinarian informed the APSS staff that the cat stopped seizuring. The APSS veterinarian stated that these signs are suspected from a permethrin product. The product was not used according to label directions. The veterinarian who treated the cat reported to APSS that a product labeled for use on dogs only was applied on the cat.