Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2760
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0026800 (Report 491707)
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.
04-JUN-18
5. Location of incident.
Country: UNITED STATES
Prov / State: OREGON
6. Date incident was first observed.
03-JUN-18
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. 11556-152
Product Name: Advantage II Large Cat
- 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.
.8
Units: mL
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 03-Jun-2018, a 6 year old, 19 pound, neutered, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (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?
Yes
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
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
8.618
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 h
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
Four hours after application the cat died.
No necropsy was performed.
No further information is expected. This case is closed.
Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
Reported 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 over dosage tolerated by cats without showing any side effect. Previous administration was well tolerated by the animal without any adverse event. Time to onset is short though. Finally, even though some information is not available (e.g. animal health status, medical history and necropsy results), considering known safety profile of the product a product relation is unlikely.