New incident report
Incident Report Number: 2017-4940
Registrant Reference Number: USA-BAYERBAH-2017-US0042603
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: FLORIDA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
CollarYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
>6 mos / > 6 mois
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date, in approximately 2015, post collar application, the cat exhibited application site hair loss. On an unspecified date, in approximately 2017, the cat died.
Death
The reporting party contacted Bayer Animal Health to inquire about a product defect with a different pet and not to report the death of this animal. This case is closed. N-Unlikely: The reported application site hair loss may occur in sensitive animals after product application. It is usually mild and transient. Sign is consistent. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats for an 8 months period without causing serious signs. Time to onset is unknown for application site reaction, where as it is exceptionally long for the serious outcome. Further, caller does not believe in product connection as the reason for the initial phone call was to discuss about a product defect with a different pet and not to report the death of the patient. Finally, though initial non-serious sign is deemed product related, a relation with death can be clearly ruled out. The case was finally classified as unlikely.