New incident report
Incident Report Number: 2018-2332
Registrant Reference Number: USA-BAYERBAH-2018-US0021308 (Report 486714)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: MARYLAND
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9advantixII pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Doberman Pinscher
1
Male
12
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately Jul 2017 the dog had a torn toenail. The dog presented to the veterinarian for weekly bandage changes. The product continued to be applied monthly with the most recent application being on an unknown date in approximately Oct 2017. On an unspecified date in Oct 2017 the dog presented to the veterinarian for a bandage change. While the dog was at the veterinary clinic he had gastric dilation (Bloat) and died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained. The reason for the phone call was to discuss product on a different pet and not to report the death in this event. No new information is expected. Case is closed.
Death
N - Unlikely Reported torn nail is not expected in dogs after product application. Likely the dog injured himself, e.g. while walking on hard surface. Later reported gastric dilatation and subsequent death is also unexpected. Deep-chested breeds such as Dobermann are at risk of developing such signs. Moreover, time for reporting is long (10 Months) as the intent of the phone call to Bayer was to discuss product on a different and not to report the death in this event. Even though time to onset is unknown, considering known pharmaco-toxicological product profile and dog breed, a product connection is deemed unlikely.