Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0032
2. Registrant Information.
Registrant Reference Number: 090136309
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-DEC-09
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
08-DEC-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).
On December 8, 2009 the owner's friend inappropriately applied the product to the cat.
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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.58
7. Weight (provide a range if necessary )
10
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
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 December 8, 2009 the owner bathed the cat . The APSS veterinarian stated cats are very sensitive to concentrated permethrin. The APSS veterinarian recommended the cat be monitored at home for worsening signs, and if those signs do occur, to take the cat to the veterinarian and have the veterinarian call for information. Later on the December 8, the owner called the APSS back to update the case. The owner stated the cat was doing better. The APSS technician recommended the owner still monitor the cat closely, and if signs increase in severity, the cat should be taken to an emergency clinic.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a high likelihood of causing the clinical situation. Multiple attempts to update the case were unsuccessful; therefore, the outcome is unknown. This product was not used according to label directions: Do not use on cats.