New incident report
Incident Report Number: 2019-7166
Registrant Reference Number: USA-BAYERBAH-2019-US0068170 (Report 610753)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
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. 11556-155
Product Name: Seresto collar Large
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage Plus spot-on unknown size
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Mastiff
1
Unknown
10
113.4
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post application, in 2019, the canine exhibited pruritus. On an unknown date Jul-2019, the pruritus improved. On an unknown date in approximately Oct 2019, the canine had a torn cruciate ligament and was unable to rise. The canine died and no known necropsy was performed. Follow-up information received on 21st Nov 2019: No further information is expected.
Death
Pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) have to be considered as well. Initial pruritus may represent a reaction to the collar in a sensitive animal. Later reported torn cruciate ligament is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Unable to rise is likely associated with reported torn ligament. 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 signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is unknown for pruritus but it is long for other clinical signs. Other unrelated causes are more probable in this geriatric animal. Considering low level of information (health status, medical history and necropsy report are unknown), a relation to this case is considered as unassessable.