New incident report
Incident Report Number: 2017-3239
Registrant Reference Number: US-BAYERBAH-2017-406619
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. Unknown
Product Name: advantage II pipette size unknown
Other (specify)
Spot-on solutionYes
Unknown
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
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
2016-08-25 13:47:24 by (name) : Call Notes: 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 clarify which of the products were used on each of the cats that had died.
Death
N - Unlikely Death is not expected as inconsistent with pharmacotoxicological product profile and experience. 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. No signs of allergic/anaphylactic reaction reported. Moreover, the information regarding the death of the cat was casually provided during an inquiry, which too was possibly intended for another organisation (Pet meds). Finally, even though some information (e.g. time to onset, necropsy results, particular of the animal, pipette size) was missing, considering known product profile and intent of caller, a product involvement is deemed to be unlikely.