New incident report
Incident Report Number: 2017-3237
Registrant Reference Number: US-BAYERBAH-2017-406598
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: WASHINGTON
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II large cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Caller was difficult to follow. She reported that three of her cats died that previously used the medication but was not calling to report a fatality. She was wondering if the product had an expiration date. She also was confused and that we were also 1-800 Pet Meds and was trying to ask about ordering. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Place of purchase: Other Animal to animal exposure?: Unknown Misuse: NA/Unknown Case status: Closed No more information is expected. The case is closed. No known necropsy was performed. Call Review: Both large and small cat products were found in a drawer from previous pets. She did not clari fy which of the products were used on each of the cats that had died.
Death
N - Unlikely Death is not anticipated with appropriate product use as inconsistent with the pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Moreover, the information regarding the death of the cat was casually provided during an inquiry, the caller contacted Bayer Animal Health to inquire about expiration date of the used products and not to report death. Overall, even though some information is not provided (animal details, medical history, health status, time to onset and necropsy reports), considering the safety profile of the product, a product relation is unlikely.