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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6197

2. Registrant Information.

Registrant Reference Number: 140092807

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.

25-JUL-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-JUL-14

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. 23121      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovicollar for Dogs

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 18, 2014 the owner put the collar onto the dog.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Rottweiler

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

114.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 mo <=2 mos / > 1 mois < = 2 mois

11. List all symptoms

System

  • Skin
    • Symptom - Edema

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?

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 20, 2014 the owner noticed the dog's neck and face was swollen. The owner took the dog to the veterinary clinic, where the attending veterinarian gave lidocaine (remicaine). The owner returned home where they removed the collar and bathed the dog. On July 21, 2014 the edema had ended and the dog had fully recovered. On August 1, 2014 the attending veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian stated this product has a wide margin of safety. The APSS veterinarian also stated some animals may react to the plastic. The APSS veterinarian further stated she would not expect edema though, especially over a month later. The APSS assistant recommended calling back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.