Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-5818
2. Registrant Information.
Registrant Reference Number: 080098005
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.
02-SEP-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
31-AUG-08
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. 26493
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.66
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 August 31, 2008, the owner inappropriately applied the wrong dose of product to her 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
Shih Tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3.5
7. Weight (provide a range if necessary )
12
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
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
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 2, the Animal Product Safety Service (APSS) veterinarian recommended the owner give her dog a bath using liquid dish washing soap, apply Vitamin E to the application site, monitor her dog at home, 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
Per owner update, her pet's vocalization has ceased, but her pruritis and agitation are ongoing. The APSS staff member recommended that the owner call her regular veterinarian for recommendations and call back with questions.