New incident report
Incident Report Number: 2017-4951
Registrant Reference Number: USA-BAYERBAH-2017-US0046888
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. 11556-117
Product Name: Advantage 10 Topical Solution
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
2.268
kg
Skin
Unknown / Inconnu
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
No
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 6 hours post administration, the canine developed halitosis that smelled like product. The canine recovered the next day with no medical treatment. On an unknown date in 2003 post application the canine died. No necropsy was performed.
Death
The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. This case is closed. N-Unlikely:The product is not expected to cause halitosis in the treated dog. As oral ingestion of product was not reported, other causes (e.g. diet, tartar) have to be considered in this case. Apart from that, the smell of any agent is subjective to the individual concerned. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. No signs of allergy/anaphylactic reaction reported. Further, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Finally, even though some information is missing (medical history, time to onset for serious sign and necropsy result) considering known product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.