Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-6454
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0053841 (Report 440004)
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.
18-AUG-17
5. Location of incident.
Country: UNITED STATES
Prov / State: OHIO
6. Date incident was first observed.
01-MAY-17
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
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 approximately 01-Apr-2017, a feline, of unknown signalment and condition, with a concomitant medical condition of cancer, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.
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
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?
>3 days <=1 wk / >3 jours <=1 sem
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?
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On approximately 01-May-2017, the cat died. No known necropsy was performed.
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 not expected after product application, as inconsistent with pharmaco-toxicological product profile. The reason for the initial call was to discuss an adverse event that occurred with a different pet and not to report the death in this event. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. 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. The cat had medical condition of cancer which may have contributed to the outcome. Though some details are not known (state of health, necropsy details), considering alternate cause and long time to onset, a product relation is considered unlikely.
The intent of the call was to discuss product use on another pet and not to report the death of the cat.