Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-3385
2. Registrant Information.
Registrant Reference Number: 080047934
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.
07-MAY-08
5. Location of incident.
Country: UNITED STATES
Prov / State: TEXAS
6. Date incident was first observed.
07-MAY-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 Small Size Dogs 16 to 30 lbs
- 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.
.034
Units: oz (fl) / oz (liquide)
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 6, 2008, the owner applied the incorrect dosage of the product to her 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
Bulldog
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
40
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
- Nervous and Muscular Systems
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
The APSS veterinarian stated that the signs the animal was experiencing were not consistent with those expected from exposure to this product. She recommended the animal be taken to a veterinary clinic and that the attending veterinarian call the APSS for additional information. On May 9, 2008, the owner called to update the case and informed the APSS staff that the animal had died before she could take him to a veterinary clinic. The APSS veterinarian recommended a necropsy, but the owner declined. Incorrect dosage was applied.
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 this product was related to the clinical situation.