New incident report
Incident Report Number: 2018-2747
Registrant Reference Number: USA-BAYERBAH-2018-US0034067 (Report 500137)
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: UNKNOWN
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
Female
15
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
System
Persisted until death
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2018 after collar placement, the dog was diagnosed with unspecified liver failure. On an unknown date in Jun 2018, the dog died. It is unknown if the dog received any treatments. It was unknown if a necropsy was performed. Due to the sensitive nature of the communication specific relevant details were not obtained nor will they be sought. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported sign liver failure and death of the animal is not expected after product administration as not in line with pharmaco toxicological product profile. Oral exposure to the collar is not expected to cause such 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. Other unrelated causes (e.g. underlying liver disorder) must be considered in this geriatric animal. Time to onset for initial reported sign is unknown but long for death of the animal. Considering low level of information (animal health status, medical history and necropsy report are unknown), a product relation is unassessable.