Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-0539
2. Registrant Information.
Registrant Reference Number: 080121717
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.
30-OCT-08
5. Location of incident.
Country: UNITED STATES
Prov / State: NEW JERSEY
6. Date incident was first observed.
30-OCT-08
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. 2724-254
Product Name: Zodiac Fleatrol Flea and Tick Control Collar for Small Dogs
- Active Ingredient(s)
- 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 October 30, 2008, the owner applied the product to her dog as a form of prevention.
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
Shih Tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
4.5
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Seizure
- Symptom - Collapse
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
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
The collar was not sized properly, allowing the dog to chew on it. The owner took the collar away from the dog and tried to give her some water. The owner took the dog to the veterinarian. The APSS veterinarian stated that the time of exposure, severity of the signs, and death are poorly compatible with the product. A necropsy was performed, but preliminary results did not reveal the cause of death.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian doubted that the substance was related to causing the clinical situation. Histopathology, bacteriology, and toxicology results are pending.