New incident report
Incident Report Number: 2017-6449
Registrant Reference Number: USA-BAYERBAH-2017-US0052398 (Report 438349)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
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
On an unspecified date in 2017, post application, the dog had an unspecified surgical procedure performed by the veterinarian. On a separate unspecified date in 2017, post application, the dog died. No known necropsy was performed.
Death
N- U nlikely- 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 and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Previous exposure was well tolerated by the animal. Moreover, the reason for the initial call was to discuss a product use on a new pet and not to report the death in this event. Even though some information (e.g. time to onset and necropsy results) is not available considering the known safety profile of product, a product involvement is deemed to be unlikely. The reason for the initial call was to discuss a product use on a new pet and not to report the death in this event. This case is closed.