Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-2323
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0019490 (Report 484511)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississauga
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.
09-MAY-18
5. Location of incident.
Country: UNITED STATES
Prov / State: OHIO
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. 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 an unspecified date in approximately 2015, a feline, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the 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?
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.
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 post application, in approximately 2015, the cat died.
No necropsy was performed.
Due to the sensitive nature of the communication, specific to relevant details were not obtained nor will they be sought. The intent of the call was not to report this event, but to inquire about product use on another cat.
No more information is expected; this 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. Furthermore, the intent of the call was not to report death, but to inquire about product use on another cat. Moreover sign would have been reported in close proximity and not 3 years later. Finally, even though some information is missing (necropsy details, medical history) sufficient information exists to rule out product relation completely. Hence an overall product relation is considered as unlikely.