Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1129
2. Registrant Information.
Registrant Reference Number: 070105349
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-OCT-07
5. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
04-OCT-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. 2724-497-270
Product Name: Bio Spot Spot On Flea and Tick Control For Large Dogs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3 %
- PERMETHRIN
- Guarantee/concentration 45 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
3
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 October 3, 2007 the owner applied the product to his lactating bitch. The product was not applied directly to the puppies. The puppies may have been exposed through dermal exposure to the mother or by nursing.
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
Great Dane
4. Number of animals affected
8
5. Sex
Unknown
6. Age (provide a range if necessary )
0.04
7. Weight (provide a range if necessary )
4
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
12. How long did the symptoms last?
Unknown / Inconnu
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?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On October 4, 2007 the owner found all 8 puppies dead. On October 5, 2007 the APSS staff member stated that all 8 would not be expected to die. Puppies were also treated with a dewormer product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Label directions state product not to be used on nursing animals without consulting veterinarian. Since all 8 puppies have already been cremated, necropsy was not an option. APSS veterinarian stated puppies may have had infection, virus, blockage from worms or parasite problem. APSS stated that it was doubtful that exposure to this product led to the clinical situation.