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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0030

2. Registrant Information.

Registrant Reference Number: 090134465

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.

04-DEC-09

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

29-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. 21206      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Plus Flea Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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 November 29, 2009 the owner applied the product to both cats.

To be determined by Registrant

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

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

Female

6. Age (provide a range if necessary )

0.83

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling
    • Symptom - Vomiting
  • Skin
    • Symptom - Itchy skin

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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 November 29, 2009 the owner bathed the cat with human shampoo. On December 4, 2009 the APSS veterinarian stated a dermal tingling feeling reaction or a dermal allergic reaction may develop. He also stated a taste reaction and gastrointestinal signs may develop. The APSS veterinarian recommended the owner take the cat to the veterinarian to discuss ways to eliminate fleas and have the veterinarian call for information.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On December 6, 2009 an APSS technician called the owner to follow up the case. The owner stated the cat still has pruritus. She informed the APSS technician that she had used a flea comb and asked about using antihistamines. The APSS technician relayed the APSS veterinarian's recommendations regarding antihistamine use, by informing the owner that they will likely not be of benefit.

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

Female

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Vocalizing
  • Skin
    • Symptom - Hair loss
    • Symptom - Dermatitis
    • Specify - Focal Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

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 November 29, 2009 the owner bathed her with human shampoo. On December 4, 2009 the APSS veterinarian stated a dermal tingling feeling reaction or a dermal allergic reaction may develop. He also stated a taste reaction and gastrointestinal signs may develop. The APSS veterinarian recommended the owner take the cat to the veterinarian to discuss ways to eliminate fleas and have the veterinarian call for information.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On December 6, 2009 an APSS technician called the owner to follow up the case. The owner stated the cat's signs continue. She informed the APSS technician that she had used a flea comb and asked about using antihistamines. The APSS technician relayed the APSS veterinarian's recommendations regarding antihistamine use, by informing the owner that they will likely not be of benefit.