Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-3247
2. Registrant Information.
Registrant Reference Number: US-BAYERBAH-2017-409837
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
01-JUN-17
5. Location of incident.
Country: UNITED STATES
Prov / State: CALIFORNIA
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. Unknown
Product Name: advantage II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Other (specify)
Spot-on solution
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).
Body weight of animal and applied pipette size of AdvantageII is unknown.
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 Shorthair
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
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
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?
Other / Autre
specify Unknown
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Event Narrative: At an unknown date, in 2016, the cat died. It is unknown whether it was evaluated by a veterinarian. No known necropsy was performed. No more information is expected. The case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Death is inconsistent with pharmaco-toxicological product
profile and experience. No signs of allergic/anaphylactic
reaction reported. Product has wide margin of safety. Oral
LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated
by cats without showing any side effect. Though some
information is not available (e.g. state of health, age, time to
onset and necropsy result) considering the known safety
profile of the product, a product relation is unlikely.