Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3014
2. Registrant Information.
Registrant Reference Number: 2014CK236
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
17-JUL-14
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. Unknown
Product Name: Advantage II unknown
- 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.
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 2013, a Retriever (Golden) canine, of unknown signalment in unknown condition, with no known concurrent medical conditions, was administered 1 tube of Advantage II (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
golden retriever
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?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Lethargy
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
Approximately one hour post application the dog exhibited lethargy.An unspecified time post application, in approximately 2013, the dog passed away. No necropsy was performed. No more information is expected. 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
Lethargy is an unspecific sign and may have multiple potential other causes, it may represent a behavioural response to the product sensation. Time to onset short. Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. Reliability of data is questionable due to limited information ( medical history, chronology, necropsy not available). Other etiologies are more probable. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Though time to onset unknown, death is inconsistent with the pharmacological product profile. Cause for death unrelated to product use. The owner initially contacted Bayer Animal Health to seek advise on how to control an active flea infestation and not to report the death of this pet. Finally, product relation considered unlikely.