Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0061
2. Registrant Information.
Registrant Reference Number: 100014562
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.
08-FEB-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
04-FEB-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 February 2, 2010 the owner applied the product to the dog for prevention.
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
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.67
7. Weight (provide a range if necessary )
1.4
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- Symptom - Loss of appetite
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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?
1
Day(s) / Jour(s)
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 February 8, 2010 the owner took the cat to the veterinarian. The APSS veterinarian stated dermal reactions can occur within the first 72 hours. The APSS veterinarian recommended bathing the dog, performing a diagnostic evaluation, and providing symptomatic care.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
On February 10, 2010 an APSS technician contacted the veterinary clinic to follow up the case. The veterinary staff stated the dog recovered after overnight supportive case and was discharged on February 9, 2010 to the owners' care.