New incident report
Incident Report Number: 2017-6535
Registrant Reference Number: USA-BAYERBAH-2017-US0036753
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar unknown
Other (specify)
collarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 10-May-2017, a canine with unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 20May2017, the canine exhibited unspecified pain, an unspecified back disorder, ataxia, lethargy, and not acting herself (behavioral disorder). The canine was examined by a veterinarian and it was unknown if treatments were performed. On 21Jun2017, the canine died and no necropsy was performed. 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 phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected. This case is closed.
Death
N - Unlikely Reported unspecified back disorder is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Reported unspecified pain and lethargy are likely associated with back disorder. Ataxia is not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported, only transient gastrointestinal sign but no neurological sign would be expected. Behavioural disorder is likely associated with ataxia. 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. Moreover, the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though, no information available (animal details, health condition, medial history and necropsy results), considering known safety profile of the product and serious outcome death, a product relation is unlikely.