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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5421

2. Registrant Information.

Registrant Reference Number: 090123009

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.

03-NOV-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-NOV-09

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control for Cats and Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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 November 2, 2009 the owner applied the product to her three cats. On November 1, 2009 a dog spot on product was applied to the dog in the household.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

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 )

4

7. Weight (provide a range if necessary )

10

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 - Muscle tremors

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?

Unknown

14. b) How long was the animal hospitalized?

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 November 3, 2009 the APSS veterinarian stated that a permethrin exposure from the dog in the household could result in tremors, seizures, hyperthermia, possibly disseminated intravascular coagulation (DIC), and death. The APSS veterinarian recommended taking the cat to the veterinarian, have the veterinarian call for information, manage seizures with methocarbamol, provide symptomatic care, bathe the cat in liquid dish washing detergent, provide fluid therapy, and monitor at a veterinary facility.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On November 3, 2009 an APSS veterinarian spoke with the veterinarian clinic to follow up the case. The APSS veterinarian discussed permethrin hair testing to help confirm that the cat had been exposed to permethrin. The veterinary staff reported that cat had fully recovered. Multiple attempts to update the case in regards to hair testing were unsuccessful; therefore, the outcome of hair testing is unknown.

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 )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Muscle tremors

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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, 2009 the APSS veterinarian stated there is a risk for dermal hypersensitivity with topical exposure and an oral exposure can result in hypersalivation and vomiting. The APSS veterinarian also stated that a permethrin exposure from the dog in the household could result in tremors, seizures, hyperthermia, possibly disseminated intravascular coagulation (DIC), and death. The APSS veterinarian recommended the attending veterinarian manage seizures with methocarbamol, provide symptomatic care, bathe the cat in liquid dish washing detergent, give fluid therapy, and monitor at a veterinary facility.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On November 4, 2009 an APSS veterinarian spoke with veterinary staff to follow up the case. The APSS veterinarian discussed permethrin hair testing to help confirm that the cat had been exposed to permethrin. Multiple attempts to update the case were unsuccessful; therefore, the outcome of is unknown.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Leopard Cat Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Muscle tremors

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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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, 2009 the APSS veterinarian stated there is a risk for dermal hypersensitivity with topical exposure and an oral exposure can result in hypersalivation and vomiting. The APSS veterinarian also stated that a permethrin exposure from the dog in the household could result in tremors, seizures, hyperthermia, possibly disseminated intravascular coagulation (DIC), and death. The APSS veterinarian recommended the attending veterinarian manage seizures with methocarbamol, provide symptomatic care, bathe the cat in liquid dish washing detergent, give fluid therapy, and monitor at a veterinary facility.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On November 4, 2009 an APSS veterinarian spoke with veterinary staff to follow up the case. The APSS veterinarian discussed permethrin hair testing to help confirm that the cat had been exposed to permethrin. Multiple attempts to update the case were unsuccessful; therefore, the outcome of is unknown.