Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-3603
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2019-US0033415 (Report 575536)
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.
21-JUN-19
5. Location of incident.
Country: UNITED STATES
Prov / State: TENNESSEE
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: K9advantixII pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .44 %
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 an unknown date in approximately 2015, a cat, of unknown signalment and condition, with no known concomitant medical conditions, was accidentally administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the veterinarian. This was used in an off label manner due to it be administered to the wrong species.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
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
>8 hrs <=24 hrs / > 8 h < = 24 h
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 unknown date in 2015, 1 day post application, the cat died. No necropsy was performed.
No further information expected. This case is close
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
B - Possible
Even though permethrin is toxic for cats, with timely and appropriate therapy cats usually have a good chance to recover. No other signs of permethrin toxicosis were reported. Other etiologies should be considered as well. Association in time. In the end, a product relation cannot be excluded and is considered possible