Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-6019
2. Registrant Information.
Registrant Reference Number: 2010CP042US
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.
18-OCT-10
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
24-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.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: advantage
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
7. b) Type of formulation.
Liquid
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).
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
Cat / Chat
3. Breed
domestic
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
Unknown
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
- General
- Symptom - Death
- Symptom - Cancer
- Specify - oral cancer
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
Owner called to report that she last applied Advantage to her cat in February 2010. She had used Advantage on her cat for several years. She is concerned that the long-term use of Advantage caused her cat to develop oral cancer. The cat died approximately 24Feb10. The owner was also concerned that bleach, her leather shoes, or fur coats may have caused the oral cancer in her cat. No more information is expected, as the cat is dead and there was no product lot number provided.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Information in this case limited, as no medical record available. Product has been used on cat for years without adverse signs. Reported signs not consistent with product`s pharmaco-toxicological profile. No long-term effects expected from regular use of product. It remained unclear when cancer started and if there was temporal association with product application. Owner suspects other agents to be responsible for cat`s signs as well.