Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0202
2. Registrant Information.
Registrant Reference Number: 100109065
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-AUG-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
18-AUG-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. 26494
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 18, 2010 the owner applied the product to the dog after seeing one flea.
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
Bichon Frise
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
12
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Specify - Rubbing application site
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
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 August 18, 2010, almost immediately after product application, the owner noticed that the dog was symptomatic. She contacted the Animal Product Safety Service (APSS) on August 20. The APSS technician stated that dermal hypersensitivity can be seen, but signs should be self-limiting. She recommended bathing the dog with cool water and liquid dish washing detergent, keeping the dog warm after bathing without rubbing or blowing her coat dry, applying Vitamin E to the application site, monitoring at home, and calling 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 August 24, 2010 an APSS assistant called the pet owner to update the case. The owner's husband informed her that the dog had made a full recovery the morning after the consultation.