New incident report
Incident Report Number: 2018-3601
Registrant Reference Number: USA-BAYERBAH-2018-US0037469 (Report 504374)
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: NORTH CAROLINA
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
Unknown
6
Unknown
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 30-Jun-2018, the canine was left in an non-air conditioned house and died from hyperthermia. No known medical intervention or necropsy was performed. No further information is expected. This case is closed. 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 call was to request product refund and was not to report the death of the patient. Note: Previous exposure was well tolerated by the animal.
Death
N - Unlikely Reported hyperthermia and death are 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. The previous exposure was well tolerated by the animal. The canine was left in an non-air conditioned house and died from hyperthermia. Moreover, the reason for the initial call was to request product refund and was not to report the death of the patient. Time to onset is short. Although, no necropsy was performed, considering all aspects, a product involvement is unlikely.