Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-2157
2. Registrant Information.
Registrant Reference Number: 2017KP103
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.
19-APR-17
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. Unknown
Product Name: advantage II unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
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).
On an unspecified date in May 2016, a feline of unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II(unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.
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
Cat / Chat
3. Breed
Unknown
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?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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 May2016 post application the cat died. No necropsy was performed. No further information is expected. This case is closed. The intent of the call was to discuss frequency of application and not to report this event.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Further the owner did not believe in product involvement either as the intent of the call was to discuss frequency of application and not to report this event. Even though some information is not available (animal details, health condition, medical history, time to onset and necropsy report ), sufficient information exists to rule out product relation completely. Finally, a product involvement is considered as unlikely.