Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-2178
2. Registrant Information.
Registrant Reference Number: 2017KP122
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.
19-APR-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. 11556-135
Product Name: k9 advantix 55
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 2005, a female, Welsh Corgi Cardigan canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered1 tube of K9 Advantix 55 (Imidacloprid - Permethrin) topically by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Dog / Chien
3. Breed
Welsh Corgi Cardigan
4. Number of animals affected
1
5. Sex
Female
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
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.
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 an unspecified date in 2005, the dog passed away. No necropsy was performed. It is unknown if the dog was examined by a veterinarian and if any treatments were performed. No further information is expected. This case is closed. Note from LDSM: The intent of the call was to inquire about bathing with
application of K9 Advantix II 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
Reported death is not expected in dogs after product application, as it is inconsistent with pharmacotoxicological product profile. Very long time (approximately
12 years) for reporting as the intent of the call to Bayer was to inquire about bathing with application of K9 Advantix II and not to report this event. No signs of
allergy/anaphylactic reaction reported. Even though time to onset is unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other etiologies more probable. Finally though time to onset is unknown and necropsy was not performed, considering overall aspects, a product connection is deemed to be unlikely.