Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-0578
2. Registrant Information.
Registrant Reference Number: 2011CP122
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.
29-SEP-11
5. Location of incident.
Country: CANADA
Prov / State: NEW BRUNSWICK
6. Date incident was first observed.
22-SEP-11
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. Unknown
Product Name: K9advantix
7. b) Type of formulation.
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).
one tube was applied to dorsal midline in several spots
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
Dog / Chien
3. Breed
duck toller
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
26
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Fainting
- Symptom - Unconsciousness
12. How long did the symptoms last?
<=30 min / <=30 min
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
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
owner reports that 3 days after application , in September, dog collapsed and was unconscious for a few seconds. Product was used in August without any side effects. Blood tests are all normal. No treatment was given
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs not anticipated with appropriate topical product administration; long onset time of 3 and a half days; unlikely to be related