Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-5073
2. Registrant Information.
Registrant Reference Number: 120055523
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.
30-APR-12
5. Location of incident.
Country: UNITED STATES
Prov / State: OKLAHOMA
6. Date incident was first observed.
29-APR-12
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: Bio Spot Spot On Flea And Tick Control For Cats Less than 5 lbs
- 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.
.068
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 April 29, 2012 the owner inappropriately applied two doses of the product to the cat to prevent fleas. The owner suspected that the cat also ingested some of the product.
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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
15.0
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Drooling
- Symptom - Vomiting
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 April 29, 2012 the owner noticed that the cat was depressed and drooling, and she bathed the cat with liquid dish washing detergent (LDWD). Later that afternoon he had an isolated episode of vomiting, and she once again bathed the cat with LDWD. Later that day, the owner observed that the cat died. On April 30, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian also stated that significant neurologic signs would not be expected with the appropriate use of the etofenprox product. 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 APSS veterinarian stated that the substance was not related to the clinical situation. A follow up was not performed, because additional information was not expected. Label states: This product contains 3 monthly doses, each 0.061 fl oz (one monthly dose). Do not apply more than once every month.