Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0081
2. Registrant Information.
Registrant Reference Number: 120049045
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.
18-APR-12
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-APR-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. 26493
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerspot 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.
2
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 April 17, 2012 the owner applied the product to 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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Beagle Mix
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.67
7. Weight (provide a range if necessary )
59.5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Nervous and Muscular Systems
- Symptom - Muscle weakness
- Specify - Hind Limb Weakness
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?
Yes
14. b) How long was the animal hospitalized?
Unknown
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 the evening of April 17, 2012 the owners noticed that the dog was symptomatic. A short time later that evening the owners bathed the dog. On April 18, 2012 the owners took the dog to the veterinarian, where a complete blood count, chemistry profile, and heartworm test were performed and methocarbamol was administered. Later that afternoon the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian recommended that the owners apply vitamin E to the application sites and referred the owner to the manufacturer to discuss reimbursement. The APSS veterinarian also recommended that the regular veterinarian 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 expected to be mild and self limiting.