Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-1429
2. Registrant Information.
Registrant Reference Number: 150160313
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.
20-NOV-15
5. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
6. Date incident was first observed.
14-NOV-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. 2724-504-270
Product Name: Adams Spot On Flea And Tick Control For Cats 5 Lbs And Over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 40 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.8
Other Units: cc
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 November 4, 2015 the owner applied the product onto and unknown age and weight cat for prevention.
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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Lethargy
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Unknown
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 November 14, 2015 the cat developed lethargy. On November 16, 2015 the owner took the cat to the veterinarian where antibiotics and fluids were given. On November 17, 2015 the cat died. On November 20, 2015 the company received an email from the owner. The company veterinarian stated topical use of synthetic pyrethroid-like flea preparations as per label directions is not expected to cause significant clinical signs. The owner did not provide a phone number so the company assistant sent the owner an email providing the Animal Product Safety Service (APSS)'s phone number. A necropsy was not available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The company veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.