Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-1018
2. Registrant Information.
Registrant Reference Number: 160168276
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.
11-NOV-16
5. Location of incident.
Country: UNITED STATES
Prov / State: NORTH CAROLINA
6. Date incident was first observed.
28-OCT-16
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. 2724-829-89459
Product Name: Bio Spot Active Care Flea and Tick Spot On for Dogs Puppies 5-14 lbs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .23 %
- ETOFENPROX
- Guarantee/concentration 50 %
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- Guarantee/concentration .91 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .45 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 28, 2016 the dog was lethargic and the owner applied the product onto the dog to treat condition.
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
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7.0
7. Weight (provide a range if necessary )
6.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
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 October 28, 2016 the owner noticed the dog developed diarrhea. On October 29, 2016 the owner found the dog dead. On November 11, 2016 the owner called the Animal Product Safety Service (APSS). A necropsy was not possible as the body had been buried. The APSS veterinarian recommended 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 an unknown likelihood of causing the clinical situation.