New incident report
Incident Report Number: 2019-3155
Registrant Reference Number: USA-BAYERBAH-2019-US0024906 (Report 566593)
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. 11556-130
Product Name: advantageII extra large dog
Other (specify)
spot onYes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
unknown
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 unknown date post application, in May 2019, the feline was heavily infested with fleas and died of unknown causes; no known necropsy was performed. No further information is expected. Case is closed.
Death
O - Unclassifiable/unassessable SLEE/fleas. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. Unknown if environment was treated to stop re-infestation via emerging pupae that are still present in the environment. In this case, product was applied previously however exact treatment start date and duration of treatment are unknown. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Other etiologies are more probable. 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. Reliability of data is questionable due to limited information (animal details, medical history, chronology, necropsy not available). Time to onset is unknown. Considering overall aspects, a product relation is unassessable.