New incident report
Incident Report Number: 2019-5939
Registrant Reference Number: USA-BAYERBAH-2019-US0058477 (Report 601390)
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: SOUTH CAROLINA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Crossbred (Dog)
1
Male
2
27.216
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Yes
1
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 26-Sep-2019, the dog was in a fight with another dog in the home and exhibited limping, multiple puncture wounds on the limbs, multiple lacerations on the limbs and excessive thirst. On 27-Sep-2019, the dog exhibited recumbency, was unable to stand or walk without assistance (walking difficulty). The dog was examined by a veterinarian, hospitalized and a complete blood count was performed. The dog was administered unspecified fluids intravenously and administered an unspecified anesthesia by the attending vet. The puncture wounds and lacerations were repaired and the dog was administered an unspecified antibiotic intravenously by the attending vet. On approximately 28-Sep-2019, the dog died.
Death
O - Unclassifiable/unassessable Reported limping, puncture wounds, laceration, excessive thirst and recumbency are not expected after topical product application. In this case, signs are likely consequence of fight with other dog. Further reported neurological disorders are not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Death is not expected following appropriate topical product application as inconsistent with product's 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. Considering the product profile, product involvement is deemed unlikely, however due to limited (animal health status, medical history, time to onset, necropsy report) information, product relation for the case is considered as unassessable.