Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-0553
2. Registrant Information.
Registrant Reference Number: 080145088
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.
28-DEC-08
5. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
6. Date incident was first observed.
23-DEC-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 On Flea And Tick Control For Large Size Dogs Over 60 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.
.101
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 December 20, 2008, the owner applied the product to her pet.
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
Dalmatian Dog
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle weakness
- Specify - Hind Limb Weakness
- Gastrointestinal System
- Symptom - Loss of appetite
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Anorexia
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 December 21, 2008, the owner gave her pet a bath. Signs the pet was experiencing would not be expected. The APSS veterinarian recommended the owner take her pet to the veterinarian and have a diagnostic evaluation done.
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 stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. The owner took the pet to the veterinarian, but a diagnostic evaluation was not done because the pet died shortly after arriving to the clinic. The APSS technician recommended a necropsy, but it was rejected, because the body was no longer available. This was off label use, consult a veterinarian before using this product on debilitated, aged, medicated, pregnant or nursing animals.