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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7235

2. Registrant Information.

Registrant Reference Number: 130094263

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.

10-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-JUL-13

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Bio Spot for Cats 5lbs and over

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 9, 2013 the owner applied the product to the cat to treat for 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 )

10.0

7. Weight (provide a range if necessary )

12.0

lbs

8. Route(s) of exposure

Skin

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

  • Skin
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - Pustules
    • Symptom - Pruritus

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 July 9, 2013 the owner noticed that the cat had erythema shortly after the product had been applied. On July 10, 2013 the owner noticed that the cat had pustules at the area of application; the owner thought that perhaps the pustules may have been pre-existing, though. Later on the morning of July 10, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal reactions are possible and are self-limiting. The APSS technician recommended that the owner bathe the cat with a liquid dish washing detergent (LDWD), apply vitamin E on the area of application, take the cat to the veterinarian if the pustules did not subside, have the veterinarian call for information, and call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On July 20, 2013 the owner contacted the APSS to update the case. The owner stated that at an unspecified time she applied vitamin E to the application site. The owner said that at an unspecified time, the cat no longer had erythema or pustules; however, the cat did have pruritus (specific date of onset was not given). The APSS veterinarian recommended that the owner take the cat to the veterinarian and treat for fleas on the cat as well as in the environment.