Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3334
2. Registrant Information.
Registrant Reference Number: 2011CP020US0007834
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-11
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
31-OCT-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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: advantage 100
- 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).
one tube was applied to animal
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
golden retreiver
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
69
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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
Owner reports Advantage 100 was applied monthly for years to [name], a 69# FS Golden Retriever. [Dog] was diagnosed with pancreatic lymphoma in June 2010 when she was 10 years old, and died on approximately 31 October 2010. Neither the owner nor the DVM suspect the product in the development of the lymphoma or [dog]'s death.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Signs are not anticipated with appropriate product administration as inconsistent with the product`s topical mode of action and pharmacological profile. A product connection has been ruled out by owner and DVM. Product has been used on dog for years without adverse signs.