Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1163
2. Registrant Information.
Registrant Reference Number: 070125093
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.
29-NOV-07
5. Location of incident.
Country: UNITED STATES
Prov / State: CALIFORNIA
6. Date incident was first observed.
29-NOV-07
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.
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Flea And Tick Collar For Cats
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 2.1 %
- PROPOXUR
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
Collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
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 November 28, 2007 the owner applied the product to her cat 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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.12
7. Weight (provide a range if necessary )
1.5
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
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 November 29, 2007 the owner took the animal to the local veterinary clinic. The animal was examined by the attending veterinarian and was given fluid therapy and atropine. On November 29, 2007 the APSS staff member stated that the product has a wide margin of safety. The APSS staff member recommended that the attending veterinarian monitor the kitten's vital and respiratory signs and continue to supply symptomatic and supportive care to the animal. The owner stated that the kitten died shortly after the APSS consultation on November 29, 2007.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Inappropriate use. Minimum age on label is 12 weeks. The kitten was 6 weeks old. The owner declined a necropsy when it was suggested by the APSS staff member. According to APSS other causes cannot be ruled out.