Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-2954
2. Registrant Information.
Registrant Reference Number: 150005005
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.
12-JAN-15
5. Location of incident.
Country: UNITED STATES
Prov / State: CALIFORNIA
6. Date incident was first observed.
22-DEC-14
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. 2724-404
Product Name: Zodiac Fleatrol Flea And Tick Spray For Dogs Cats Puppies And Kittens
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .27 %
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- Guarantee/concentration .62 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration .37 %
- PYRETHRINS
- Guarantee/concentration .2 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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).
Between December 15, 2014 and December 17, 2014 the owner inappropriately sprayed the cat with the product 1-3 times.
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Feline Domestic Unspecified
4. Number of animals affected
1
5. Sex
Unknown
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
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 22, 2014 the cat developed anorexia. On December 29, 2014 the cat died. On January 12, 2015 the attending veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian stated label use is not expected to result in significant systemic effects. The APSS veterinarian also stated if ingested, mild gastrointestinal (GI) upset and/or taste reaction may occur. The APSS veterinarian finally stated if this is alcohol based, saturation of the animal could result in central nervous system (CNS) depression and ataxia.
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. A necropsy was not completed. Off label use of product.