Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-5926
2. Registrant Information.
Registrant Reference Number: 2010CP031US
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.
15-JUL-10
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
20-JUN-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. 25128
PMRA Submission No.
EPA Registration No.
Product Name: advantage9
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
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).
Owner applied the advantage9 to his cat on 6/20/10
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
domestic
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
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
That evening the owner came back home from running errands and his cat dead on his bed. No necropsy has been done at this point. First time use of the product. Cat has an unknown medical history
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death is not anticipated with appropriate product administration as non-consistent with the product`s pharmacological profile. According to the case description, the cat was unwatched for a certain time. Thus, other unknown etiologies have to be considered. Although a connection with the product was considered rather unlikely, without necropsy a final conclusion was considered impossible