New incident report
Incident Report Number: 2019-3134
Registrant Reference Number: USA-BAYERBAH-2019-US0022571 (Report 563821)
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: FLORIDA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Small Dog collar (Flumethrin-Imidacloprid)
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Pekingese dog
1
Male
14
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 08-May-2019, the dog exhibited eyeball protrusion. The dog was evaluated by the veterinarian and no known treatments were performed. On 10-May-2019, the dog died and no necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. MAH Comment: This collar is suspected counterfeit.
Death
O - Unclassifiable/unassessable This collar is suspected counterfeit. Nevertheless, for genuine product reported eyeball protrusion is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. No ocular exposure occurred. Other causes are more probable to generic animal, e.g. breed specifics. Further, 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. Moreover, the intent of the call was to inquire about product use in general and not to report this event. Time to onset is long. Even though, no necropsy performed. Taking into consideration all aspects, especially reported suspected counterfeit, the causality remains unassessable.