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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-0041

2. Registrant Information.

Registrant Reference Number: 110081135

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.

28-JUN-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

21-JUN-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. 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 June 21, 2011 the owner applied the product to her 2 cats.

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

Other

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 )

8.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • Skin
    • Symptom - Pruritus
    • Symptom - Dermatitis
    • Specify - Acute Moist Dermatitis
    • Symptom - Hair loss

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 the evening of June 21, 2011 the owner noticed the cat was symptomatic. On June 23, 2011 the cat's anorexia and vomiting had ended, but the cat had developed acute moist dermatitis and alopecia later that day. On June 28, 2011 the owner bathed the cat with an herbal pet shampoo. Later that day, an employee at a pet store contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician state that signs should be self-limiting. The APSS technician advised the employee to refer the animal owner to the APSS.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On June 28, 2011 the owner called the APSS to update the case. The APSS assistant recommended that the owner bathe the cat with liquid dish washing detergent (LDWD), apply vitamin E oil to the application site, take the cat to the veterinarian, have the veterinarian call back with questions, and to call back with her own questions. On July 18, 2011 an APSS assistant called the owner to update the case. The owner stated that she had not implemented any of the planned cares, that the pruritus and acute moist dermatitis had ended on June 30, 2011, and that the alopecia continued.

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

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 )

8.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Vomiting
  • Skin
    • Symptom - Pruritus
    • Symptom - Dermatitis
    • Specify - Acute Moist Dermatitis
    • Symptom - Hair loss

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 the evening of June 21, 2011 the owner noticed the cat was symptomatic. On June 22, 2011 the symptoms stopped. On June 23, 2011 the cat developed acute moist dermatitis and alopecia. On June 28, 2011 the owner bathed the cat with an herbal pet shampoo. Later that day, an employee at a pet store contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that dermal hypersensitivity could be seen from the exposure and that signs should be self-limiting. The APSS technician advised the employee to refer the animal owner to the APSS.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On June 28, 2011 the owner called the APSS to update the case. The APSS assistant recommended that the owner bathe the cat with liquid dish washing detergent (LDWD), apply vitamin E oil to the application site, take the cat to the veterinarian, have the veterinarian call back with questions, and to call back with her own questions. On July 18, 2011 an APSS assistant called the owner to update the case. The owner stated that she had not implemented any of the planned cares, that the pruritus and acute moist dermatitis had ended on June 30, 2011, and that the alopecia continued. Signs should be self-limiting.