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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0945

2. Registrant Information.

Registrant Reference Number: 110092064

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.

19-JUL-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-JUL-11

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot 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.

2

Units: mL

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 18, 2011 the owner innapropriately applied the product to 2 cats.

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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

1.8

kg

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 - Muscle tremors
    • Symptom - Seizure
  • General
    • Symptom - Hyperthermia

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement 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 19, 2011 the owner noticed the cat had symptoms. Later that morning, the owner contacted the Animal Product Safety Service to obtain help. The APSS veterinarian stated that the exposure of cats to concentrated permethrins can result in significant central nervous system (CNS) signs. The APSS assistant recommended that the owner take the cat to the veterinarian and have the veterinarian call for information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Later on July 19, 2011 the owner's regular veterinary clinic's staff contacted the APSS to update the case. The APSS veterinarian recommended that the regular veterinarian administer 55 to 220 milligrams per kilogram (mg/kg) of Methocarbamol, not to exceed 330 mg/kg/day; administer diazepam as an adjunct to the Robaxin; provide fluid therapy; monitor the cat's body temperature; provide thermoregulation; bathe the cat with liquid dish washing detergent (LDWD); provide symptomatic care; manage seizures using diazepam, propofol, etc.; and call back with questions. Later on July 19, 2011 the regular veterinarian contacted the APSS to update the case. The regular veterinarian reported that the cat was hyperthermic, with a temperature of 40.8 degrees Celcius, and was having seizures. On July 20, 2011 an APSS assistant contacted the clinic to update the case. The regular veterinarian stated that on July 19, 2011 the cat had been given fluid therapy, the body temperature was monitored and thermoregulation was provided, symptomatic care had been provided, and Methocarbamol was administered to the cat. Shortly after the Methocarbamol was administered, all of the signs ended and the cat made a full recovery.

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 )

2.0

7. Weight (provide a range if necessary )

2.72

kg

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

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Nervous and Muscular Systems
    • Symptom - Fasciculations

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement 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 19,2011 the owner noticed the cat had symptoms. Later that morning, the owner contacted the Animal Product Safety Service to obtain help. The APSS veterinarian stated that the exposure of cats to concentrated permethrins can result in significant central nervous system (CNS) signs, tremors, and seizures. The APSS assistant recommended that the owner take the cat to the veterinarian and have the veterinarian call for information.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. Later on July 19, 2011 the owner's regular veterinary clinic's staff contacted the APSS to update the case. The APSS veterinarian recommended that the regular veterinarian administer 55 to 220 milligrams per kilogram (mg/kg) of Methocarbamol, not to exceed 330 mg/kg/day; administer diazepam; provide fluid therapy; monitor the cat's body temperature; provide thermoregulation; bathe the cat with liquid dish washing detergent (LDWD); manage seizures using diazepam, propofol, etc.; and call back with questions. Later on July 19, 2011 the regular veterinarian contacted the APSS to update the case. The regular veterinarian reported that the cat was having fasciculations. On July 20, 2011 an APSS assistant contacted the clinic to update the case. The regular veterinarian stated that on July 19, 2011 the cat had been given fluid therapy, the body temperature was monitored and thermoregulation was provided, and Methocarbamol was administered to the cat. Shortly after the Methocarbamol was administered, all of the signs ended and the cat made a full recovery.