Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-0282
2. Registrant Information.
Registrant Reference Number: PRD - 2007006926
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-NOV-07
5. Location of incident.
Country: UNITED STATES
Prov / State: SOUTH CAROLINA
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.
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.
10. Site pesticide was applied to (select all that apply).
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
domestic short hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10
7. Weight (provide a range if necessary )
6
kg
8. Route(s) of exposure
Skin
Unknown
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- General
- Symptom - Swelling
- Specify - sub cutaneous nodules, swelling
- Symptom - Other
- Specify - diffused mast cell tumors over its body
12. How long did the symptoms last?
>1 mo and <= 2mos / >1 mois et < = 2mois
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
Unknown
15. Outcome of the incident
Euthanised / Euthanasie
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
DVM reports his client states she applied the product in October. Product not purchased at DVM and DVM was not able to confirm product used. Cat developed diffuse mast cell tumors over it's body. Cat was given supportive care then euthanized on 11-19-07. Cat was treated with fluids ,pepcid and antibiotics.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
DVM does not feel this is related to the product and has consulted with veterinary oncologists who also feel it is unrelated to product usage.