Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0126
2. Registrant Information.
Registrant Reference Number: 120096086
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.
12-JUL-12
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
06-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. 28599
PMRA Submission No.
EPA Registration No.
Product Name: Vet Kem Ovitrol Dual Action Collar For Dogs And Puppies
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 July 6, 2012 the owner placed the collar on the dog 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
Dog / Chien
3. Breed
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
10.00
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
- Gastrointestinal System
- Symptom - Abnormal tongue colour
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
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
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 6, 2012 the owner noticed that the dog was symptomatic. The owner immediately removed the dog's collar and a short time later took her to the veterinarian. It is unknown what cares, if any, were given. Later that afternoon, the dog was no longer dyspneic and had fully recovered. On July 12, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that systemic effects would not be expected following a dermal exposure to the collar. The APSS assistant recommended that the owner have the veterinarian call to provide more detailed information about any veterinary care provided to the dog 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 16, 2012 the owner contacted the APSS to ask about reimbursement for the cost of medical treatment. The APSS veterinarian referred the owner to the product's manufacturer.