New incident report
Incident Report Number: 2015-3763
Registrant Reference Number: 2015CK244
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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. 1556-155
Product Name: Seresto Collar - large dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
cross
1
Female
4.5
Unknown
Skin
Unknown / Inconnu
>2 mos <=6 mos / > 2 mois < = 6 mois
System
>6 mos / > 6 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post collar application, in approximately Jun 2014, the dog was diagnosed with lymphoma.On an unspecified date in Mar 2015 the dog died. It is unknown if a necropsy was performed.Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial phone call was to discuss the product use on another pet and not to report the death of the patient.
Death
N - Unlikely. Lymphoma in canines can have various other etiologies. Because this dog had a pre-existing condition of swollen lymph nodes, it is likely that the dog had this disease before the product was used. Lymphoma and 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 death 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. Time to onset exceptionally long. The reason for the initial phone call was to discuss the product use on another pet and not to report the death of the patient. Hence, the owner is not assuming a product relation either. Considering all, a product involvement was considered unlikely.