New incident report
Incident Report Number: 2017-4040
Registrant Reference Number: USA-BAYERBAH-2017-US0014181
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-125
Product Name: advantage II medium dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Schnauzer
1
Male
16
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 2017, a 16 year old, male, Schnauzer (Miniature) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Medium Dog (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2017, the dog passed away. It is unknown if the dog was examined by a veterinarian and any treatments were performed. No necropsy was performed. No further information is expected. Case is closed. Note: Previous exposure of product was well tolerated by animal. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient.
Death
N - Unlikely Death is inconsistent with pharmaco-toxicological 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. Previous exposure of product was well tolerated by animal. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of this geriatric patient. Even though some information is not available (health status, medical history, time to onset and necropsy result), sufficient information exists to rule out product relation completely. Overall, a product relation is deemed to be unlikely.