Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-4349
2. Registrant Information.
Registrant Reference Number: 150063954
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.
16-MAY-15
5. Location of incident.
Country: UNITED STATES
Prov / State: NORTH CAROLINA
6. Date incident was first observed.
16-MAY-15
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. 2724-811-270
Product Name: Bio Spot Defense Flea And Tick Spot On For Large Dogs And Puppies
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 30 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
6
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 May 15, 2015 the owner applied the product onto the dog as prevention.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Boxer
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
68.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On May 16, 2015 the owner woke up to find the dog had died. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a wide margin of safety in dogs. The APSS veterinarian discussed in detail with the owner that significant signs are not expected. The APSS veterinarian further discussed with the owner that sudden death in Boxers can be caused by cardiac issues. The APSS veterinarian recommended a necropsy (the owner declined as she wanted the dog cremated), having the veterinarian call for information, and calling back with questions.
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.