Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0053
2. Registrant Information.
Registrant Reference Number: 150035346
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.
20-MAR-15
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-MAR-15
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
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).
Between November 1, 2014 and November 29, 2014 the owner put the collar on 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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6.0
7. Weight (provide a range if necessary )
65.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Skin
- Symptom - Dermatitis
- Specify - Acute Moist Dermatitis
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
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 March 17, 2015 the dog developed symptoms, so later that day the owner took the dog to the veterinarian where symptomatic care (topigan spray) was given. On March 20, 2015 the veterinary staff contacted the Animal Product Safety Service (APSS) to discuss the case. The APSS veterinarian stated as with any dermal exposure, contact irritation or hypersensitivity is possible. The veterinary staff stated they did not think that the signs are related to the collar and were not interested in further medical consultation. She stated they initially called to inquire if the collar can be washed. The APSS assistant transferred the caller back to the manufacturer.
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.