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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-0113

2. Registrant Information.

Registrant Reference Number: 120089591

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.

01-JUL-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUL-12

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 July 1, 2012 the owner applied the product to one cat to treat for fleas and to another cat to prevent fleas.

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 )

2.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling

12. How long did the symptoms last?

<=30 min / <=30 min

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

No

14. a) Was the animal hospitalized?

No

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 July 1, 2012, soon after the product was applied, the owner noticed that the cat was drooling; the owner suspected an oral exposure to the product. The owner immediately wiped off the cat's coat and skin with a wet wash rag. A few minutes later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product contains S-methoprene, which has a wide margin of safety, and that an oral exposure could result in a taste reaction and mild gastrointestinal (GI) upset. The APSS veterinarian recommended that the owner give the cat a taste treat, isolate the cat from another cat in the house until the application area was dry, monitor the cat for GI signs, wipe off the cat's coat and skin with liquid dish washing detergent (LDWD) and water if signs resumed, and call back with questions. During the consultation, the owner stated that she had given the cat a taste treat, and he had fully recovered at that time.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.

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 )

4.0

7. Weight (provide a range if necessary )

13.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Drooling

12. How long did the symptoms last?

<=30 min / <=30 min

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

No

14. a) Was the animal hospitalized?

No

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 July 1, 2012, soon after the product was applied, the owner noticed that the cat was drooling; the owner suspected an oral exposure to the product. The owner immediately wiped off the cat's coat and skin with a wet wash rag. A few minutes later, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the product contains S-methoprene, which has a wide margin of safety, and that an oral exposure could result in a taste reaction and mild gastrointestinal (GI) upset. The APSS veterinarian recommended that the owner give the cat a taste treat, isolate the cat from another cat in the house until the application area was dry, monitor the cat for GI signs, wipe off the cat's coat and skin with liquid dish washing detergent (LDWD) and water if signs resumed, and call back with questions. During the consultation, the owner stated that she had given the cat a taste treat, and she had fully recovered at that time.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs were expected to be mild and self-limiting.