Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-2707
2. Registrant Information.
Registrant Reference Number: 2016KP025
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.
04-MAY-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
27-DEC-15
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. 11556-130
Product Name: advantage II extra large dog
- 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).
On an unspecified date in Oct-2015, a 12.5 year old,Unknown weight , unknown reproductive status, female,Retriever (Golden) canine, in poor condition with concomitant medical conditions of blindness and deafness, was administered 1 tube of Advantage II Extra Large Dog(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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
12.5
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
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
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 27-Dec-2015 the dog died at home. It is unkinown if a necropsy was performed. No further information is expected. Case is closed. Note: The caller contacted Bayer Animal Health to inquire about using the product on the other pet in the house and not to report this event.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. The product has a wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. A 20-fold overdosage is tolerated by dogs without showing any side effect. Time to onset is exceptionally long (approximately 2 months). Moreover, the affected patient was at an advanced age and already in a poor condition with other concomitant medical conditions. Importantly, the intent of the initial call was to inquire about using the product on another pet and not to report this event. Considering all aspects, although status of necropsy is unknown, product relation is deemed to be unlikely.