New incident report
Incident Report Number: 2017-8007
Registrant Reference Number: USA-BAYERBAH-2017-US0072205 (Report 458306)
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: GEORGIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
COLLARYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Miniature Pinscher
1
Female
10
7.257
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in Oct-2017, post placement, the dog exhibited pruritus at the muzzle, sneezing, and anorexia. On an unknown date on Oct-2017, the dog was examined by a veterinarian and was administered an unknown volume of isotonic fluids intravenously. It is unknown what other treatments and diagnostics were performed. On 31-Oct-2017, the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable Reported pruritus on other than the application site is not typically seen with topical product administration. Other causes (e.g. allergies) must be considered although not described. Initial pruritus may represent a reaction to the collar in a sensitive animal. Anorexia is unspecific and may have various other causes. Sneezing is not expected after product administration as not in line with pharmaco toxicological product profile. However in this case time to onset is unknown. Later reported death is also not expected after topical product application as inconsistent with the pharmaco-toxicological product 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. Time to onset is long for death. Other unrelated causes must be consider in this case. Considering low level of information (e.g: health status, medical history and necropsy result etc. are unknown), a product relation is considered unassessable.