New incident report
Incident Report Number: 2018-2318
Registrant Reference Number: USA-BAYERBAH-2018-US0019053 (Report 483873)
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: NEW YORK
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
Other
Dog / Chien
Unknown
1
Male
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-May-2018, the dog died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will they be sought. The reason for the initial phone call was to discuss the product use on another animal and not to report the death in this event. No further information is expected. The case is closed.
Death
N - Unlikely Reported 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 sign. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. NO indication that the collar played a role in the animal's death. Further owner does not believe in product connection as, the reason for the initial phone call was to discuss the product use on another animal and not to report the death in this event. Time to onset is long. Considering known safety profile of the product, a product relation is considered unlikely.