Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-4031
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2017-US0011033
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.
30-JUN-17
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
02-SEP-16
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: Advantage II pipette size unknown
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXIFEN
- Guarantee/concentration .46 %
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).
A 10.5 year old, 37 pound, neutered, female, Setter (English) canine, in unknown condition, with concomitant medical conditions of heart enlargement and renal failure, was administered 1 tube of Advantage II (dog-unspecified) (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
Dog / Chien
3. Breed
English Setter
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.5
7. Weight (provide a range if necessary )
16.783
kg
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
On an unspecified date in Aug 2016, a 10.5 year old, 37 pound, neutered, female, Setter (English) canine, in unknown condition, with concomitant medical conditions of heart enlargement and renal failure, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.
On 02-Sep-2016 the dog died.
It is unknown if a necropsy was performed.
No further information is expected. Case is closed.
The intent of the call was to discuss product use on another pet and not to report the death of the dog.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely
The information regarding the death of the dog was casually provided during an inquiry. Death is inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. The cause of death was likely to be the medical conditions of heart enlargement and renal failure in this advanced aged canine. Finally, even though some information (e.g. necropsy results and exact time to onset) missing, a product relation is deemed to be unlikely.