Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0832
2. Registrant Information.
Registrant Reference Number: 2012BS194 - US0035984
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.
19-OCT-12
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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. 11556-120
Product Name: advantage 55
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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).
On approximately Jun 1/2011, 1 tube of advantage 55 was applied topically by owner to a 12 year old, female, Siberian Husky dog in unknown condition with history of bladder cancer.
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
Unknown
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 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- General
- Symptom - Cancer
- Specify - bladder cancer
- Symptom - Death
12. How long did the symptoms last?
Unknown / Inconnu
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 an unspecified date in October 2011, the dog passed away.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Owner called Bayer to inquire about expiration date of product, not to report death which was mentioned casually. Low level of information. Death inconsistent with pharmaco-toxicological profile. Product not carcinogenic. Onset several months. Product relation is unlikely.