Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1830
2. Registrant Information.
Registrant Reference Number: 080012584
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.
05-FEB-08
5. Location of incident.
Country: UNITED STATES
Prov / State: GEORGIA
6. Date incident was first observed.
05-FEB-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. 2724-497-270
Product Name: Bio Spot Spot On Flea And Tick Control For Medium Size Dogs 31-60lbs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3 %
- PERMETHRIN
- Guarantee/concentration 45 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
No
9. Application Rate.
10. Site pesticide was applied to (select all that apply).
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
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
Shih Tzu
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
0.33
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
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?
Other / Autre
specify The nursing mother was treated with the product. The puppy was allowed contact with the mother and also continued to nurse.
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On February 5, 2008, the owner found the puppy dead in a large amount of blood. The APSS veterinarian stated that despite the puppy¿s young age, it was at low risk of developing serious side effects from exposure to the product from the mother. Necropsy results found no permethrins in the liver. Exposure to a rodenticide is possible.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The puppy¿s mother was treated. Label indicates owners should consult with a veterinarian before applying to nursing animals. The APSS veterinarian doubted this situation was due to exposure of the product.