Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-3231
2. Registrant Information.
Registrant Reference Number: CA BAYERBAH 2017 393926
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.
01-JUN-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. 11556-151
Product Name: advantageII small cat
- 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.
.4
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).
product was applied on an unknown date in 2014
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
Domestic
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.
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
he cat passed away for other reasons,
unrelated to the product. No known necropsy was performed.
The reporting party did not contact Bayer Animal Health to report
the death of the animal but to discuss product usage with another pet
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. The information
regarding the death of the cat was casually provided during
an inquiry. The reporting party did not contact Bayer Animal
Health to report the death of the animal but to discuss
product usage with another pet. Further in case of suspected
product involvement, adverse event would have been
reported in close proximity and not long time after
(approximately 2 years). The cat died of other causes