Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0255
2. Registrant Information.
Registrant Reference Number: 100119506
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-SEP-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
12-SEP-10
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. 28360
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerband Plus Dual Action Flea and Tick Collar 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).
On September 11, 2010 the owner placed the collar onto the dog but didn't properly fit the collar to the dog.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Akbash Dog Mix
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.5
7. Weight (provide a range if necessary )
50
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Ataxia
- Symptom - Disorientation
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
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 September 12, 2010 the dog became symptomatic, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated she suspected that the signs are more due to the dog having collar stuck in its mouth. The APSS assistant relayed the APSS veterinarian's recommendations to take the dog to the veterinarian, have the veterinarian call for information. The owner requested alternative treatment at home, so the APSS assistant relayed the APSS veterinarian's recommendations to monitor the dog at home and call 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
Signs were expected to be mild and self-limiting. This product was not used according to label directions: adjust to proper fit.