Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-5457
2. Registrant Information.
Registrant Reference Number: 120072093
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.
31-MAY-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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. 2724-815
Product Name: Kirkland Signature Flea And Tick Control For Large Dogs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 30 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 May 20, 2012 the owner applied the product to the dog to treat for fleas.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Boxer
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7.5
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
No
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 an unknown date after the product was applied to the dog, the owner stated that the dog died. On May 25, 2012 the owner took the dog's body to the veterinarian, where her regular veterinarian performed a necropsy. On May 31, 2012 the owner contacted the company to obtain help. The company's veterinarian stated that death would not be expected. The call center staff recommended that the owner contact the Animal Product Safety Service (APSS) with any additional questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The company's veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.