Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-2861
2. Registrant Information.
Registrant Reference Number: 2010CP003
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
08-MAR-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
01-FEB-10
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. 25129
PMRA Submission No.
EPA Registration No.
Product Name: advantage18
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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).
one tube was applied to the dorsal midline
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
4
7. Weight (provide a range if necessary )
4
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Trembling
- Symptom - Muscle tremors
- Ear
- Symptom - Other
- Specify - bilateral ear twitching
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
1
Day(s) / Jour(s)
15. Outcome of the incident
Fully Recovered / Complètement rétabli
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
About 2 hours after application, the cat developed muscle tremors that were ongoing for one day until the cat was admitted to a veterinary clinic; no salivation was seen and no obvious oral ingestion was seen; on physical exam, cat had generalized muscle tremors cat was treated with atropine sulfate,IV, 0,1ml diazepam IV(0.5mg/ml), methocarbamol IV. Cat responded quickly to methocarbamol injection; was sent home on oral methocarbamol for 3 days. The following day, cat was rechecked and showed occasional bilateral ear twitching, otherwise was normal
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The pet owner says she applied advantage 18 to the cat; the tube went to the garbage and she cannot retrieve it; she was given the tube by a friend; that person bought it at a different veterinary clinic as an over the counter sale so there is no record of it. We are not certain that the product applied to the cat was advantage; the adverse reaction is is similar to a pryethroid type adverse reaction in cats