New incident report
Incident Report Number: 2018-2774
Registrant Reference Number: USA-BAYERBAH-2018-US0028972 (Report 493993)
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantageII pipette size unknown
Other (specify)
spot onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Mastiff
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2013 the dog died. No necropsy was performed. The intent of the call was not to report this event, but to inquire about the product use in another pet. No further information is expected. This case is closed. Due to the sensitive nature of the communication specific relevant details were not obtained nor will they be sought.
Death
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. 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. No signs of allergic/anaphylactic reaction reported. Other etiologies are more probable. Moreover, the intent of the call was not to report this event, but to inquire about the product use in another pet. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (after 4 years). Even though some information is not available (e.g. time to onset and necropsy report), sufficient information exists to rule out product relation completely. Finally a product relation consider as unlikely.