New incident report
Incident Report Number: 2017-4007
Registrant Reference Number: USA-BAYERBAH-2017-US0018583
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: PENNSYLVANIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small Dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Dachshund (Standard)-Kurzhaar
1
Unknown
Unknown
Unknown
Unknown
>15 min <=2 hrs / >15 min <=2 h
>30 min <=2 hrs / >30 min <=2 h
System
Unknown / Inconnu
No
No
Died
Other / Autre
specify Secondary Exposure
(eg. description of the frequency and severity of the symptoms
On 26-Apr-2017, a Dachssund canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions was exposed to an unknown amount of 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar as it was born to a 5 year old, 10 pound, female, lactating, Dachshund canine who was wearing the Seresto Small Dog (Flumethrin-Imidacloprid) collar that was placed around the neck by the owner on 01Apr2017. This is extra-label use of the product as the product has not been studied in pregnant or lactating animals. Approximately 1 hour post birth, the puppy died. The puppy was not examined by a veterinarian and no treatments were performed. No necropsy was performed. No more information is expected. This case is closed.
Death
O - Unclassifiable/unassessable This was off label use as the safety of the veterinary medicinal product has not been established in target animal during pregnancy and lactation however laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogen or foetotoxic effects. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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. The collar was worn by the mother for only 26 days, and it is highly unlikely that it could have caused the serious outcome of the puppy. Moreover, route of exposure to the product and reason for death is unspecified in this case. Time to onset is not consistent. Overall considering the limited amount of information, no veterinary examination or necropsy performed, product relation is unassessable.