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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-5851
2. Registrant Information.
Registrant Reference Number: 080113517
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.
09-OCT-085. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
09-OCT-08Product 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 14kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2Units: 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 October 9, 2008, the caretaker applied the product to his friend's dog as a form of treatment.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
Other
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 )
5
7. Weight (provide a range if necessary )
15
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Agitation
- Skin
- Symptom - Itchy skin
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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 October 9, 2008, the caretaker bathed the pet with dog shampoo twice. Also on the same day, the caretaker called the Animal Product Safety Service (APSS). The APSS veterinarian recommended that the caretaker re-bathe the dog using liquid dish washing detergent, apply vitamin E and cold compresses to the application site, and call back with any additional questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
On October 14th, the caretaker stated that the dog made a full recovery twenty-four hours after the signs began. This product was not used according to label directions. Label directions state: For dogs over 14 kg (30 lbs).
