New incident report
Incident Report Number: 2018-0470
Registrant Reference Number: USA-BAYERBAH-2017-US0078484 (Report 464599)
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: PENNSYLVANIA
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
Animal's Owner
Dog / Chien
Boxer (German Boxer)
1
Female
3
25.855
kg
Skin
Unknown / Inconnu
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately Jul-2016, the canine started to foam at the mouth, had difficulty breathing, collapsed, and died. The canine was not examined by a veterinarian and no necropsy was performed. Due to the nature of the communication and in order to avoid further strain on the relationship with the reporting party, no further information will be sought. No further information is expected. Case is closed.
Death
N - Unlikely Reported signs of foaming at the mouth and difficulty breathing are unspecific and may have numerous other causes. They are not expected to be seen and probably they are associated with the reported collapse. However, the reported serious sign of collapse is not expected following appropriate topical product application as inconsistent with products pharmacological 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. Subsequently reported 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 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. Other unrelated causes are more likely, e.g. heart murmur. Even though time to onset not known, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.