Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2007-8870
2. Registrant Information.
Registrant Reference Number: 070074184
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road, Suite 111
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
17-JUL-07
5. Location of incident.
Country: UNITED STATES
Prov / State: MISSOURI
6. Date incident was first observed.
16-JUL-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. 2724497
Product Name: Zodiac Spot On Flea And Tick Control For Medium Dogs 31-60 lbs2724497
- 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.
2
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 July 15, 2007 at 4:30 PM CDT, the owner applied the product to his dog.
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
Labrador Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.54
7. Weight (provide a range if necessary )
70
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Retching
- Symptom - Anorexia
- Nervous and Muscular Systems
- General
- Symptom - Dehydration
- Symptom - Adipsia
- Symptom - Death
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
The dog died on July 17, 2007 . The APSS staff recommended that the owner take the dog into the veterinarian to arrange for a necropsy. Since the APSS has not heard from the DVM, it is likely that APSS staff recommendations were not followed and a necropsy was not performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Product not used according to label directions - inappropriate dosing. The dog was underdosed, the product was for dogs up to 60 lb and the dog weighed 70 lb The Animal Product Safety Service Staff determined that this product was not related to the clinical situation.