Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0202
2. Registrant Information.
Registrant Reference Number: 090103587
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.
14-SEP-09
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
15-SEP-09
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).
Between September 13, 2009 and September 14, 2009 the pet owner inappropriately applied the product to the dog three times to treat a flea infestation.
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
Pomeranian
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
20
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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 14, 2009 the pet owner bathed the dog with shampoo. The APSS veterinarian recommended that the pet owner bathe the dog with liquid dish soap and monitor the dog at home for tremors. On September 15, 2009 the pet owner contacted the APSS to report that the dog had not developed tremors, but was pruritic. The APSS veterinarian recommended that the pet owner continue to monitor the dog at home, give diphenhydramine if needed for pruritis, 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
The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. The product was not used according to label directions: Do not reapply product for 4 weeks