Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-4953
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0047069
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.
26-JUL-17
5. Location of incident.
Country: UNITED STATES
Prov / State: GEORGIA
6. Date incident was first observed.
21-JUL-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. 11556-151
Product Name: Advantage II small 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.
.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).
1 Tube/Pipette 1 Days 1 Dose, cat was over dosed
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
Domestic Longhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
4.536
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
12. How long did the symptoms last?
>30 min <=2 hrs / >30 min <=2 h
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
Approximately 2 hours post application, the cat was found dead. The cat was not examined by a veterinarian and 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
O-Unassessable- Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. No signs of anaphylaxis was reported. A product relation is considered not likely. A connection with the concurrent use of an environmental product must be considered. Time to onset short. Although product relation is deemed quite unlikely, in particular when taking into consideration that a too low dose of product was applied, due to limited information and short time to onset, the case was considered as unassessable.