BEUDAMED
    FDA Adverse Event Other Summary report: N

    BLEEDARREST NASAL STRIP

    MDR report key: 2931631 · Received January 23, 2013

    Report

    Report Number
    3007225047-2013-00001
    Event Type
    Other
    Date Received
    January 23, 2013
    Date of Event
    December 8, 2012
    Report Date
    January 7, 2013
    Manufacturer
    HEMOSTASIS, LLC.
    Product Code
    FRO
    PMA / PMN Number
    K070211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HEMOSTASIS, LLC DOES NOT CONSIDER THE TYPE OF THIS REPORTABLE EVENT TO BE CATEGORIZED BY DEATH, SERIOUS INJURY, OR MALFUNCTION AS DESCRIBED IN 21 CFR PART 803. DEVICE LABELING CLEARLY INCLUDES INSTRUCTIONS FOR HOW LONG TO LEAVE THE PRODUCT IN PLACE AND SPECIFIC INSTRUCTIONS FOR PROPER REMOVAL FOR THE DEVICE ONCE USED. THE USER SUSTAINED NO HARM AND THE PRODUCT DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER ((B)(6)) FELL ASLEEP WITH BLEEDARREST NASAL STRIP IN NOSTRIL. WHEN HE AWOKE, HE TRIED TO REMOVE IT, BUT IT WAS DRY AND ADHERENT AND BROKE OFF, LEAVING ABOUT 2/3'S IN THE NOSTRIL. (B)(6) SAW AN ENT DOCTOR WHO FLUSHED IT OUT, BUT IT SEEMS BY HIS SYMPTOMS THAT THE FLUSHING MAY HAVE CAUSED THE RESIDUAL DEVICE TO HAVE BEEN SWALLOWED OR INHALED AND POTENTIALLY LODGED IN HIS LARYNX. (B)(6) CONTINUED TO FEEL THROAT IRRITATION AND SOUGHT THE AID OF HIS GENERAL PRACTITIONER. THIS GP CONTACTED HEMOSTASIS. HEMOSTASIS THEN CONTACTED (B)(6). (B)(6) RECEIVED A CAT SCAN TO DETERMINE WHETHER THE DEVICE WAS IN FACT STILL PRESENT 10 DAYS AFTER THE INCIDENT. IT WAS NOT. THE RESIDUAL DEVICE APPARENTLY WAS EITHER SWALLOWED OR HAD DISSOLVED NATURALLY. THE EVIDENCE IS INCONCLUSIVE AS TO WHETHER THE FLUSHING OR RESIDUAL DEVICE CAUSED (B)(6)'S THROAT IRRITATION. (B)(6) WAS CONTACTED AFTER AGAIN AND (B)(6) REPORTED THAT HE FEELS FINE. HOWEVER, THE PATIENT AND PHYSICIAN REPORTS CLEARLY INDICATE THAT THE DEVICE LABELING WAS NOT FOLLOWED. THE DEVICE IS TO BE REMOVED ONCE BLEEDING STOPS, NOT LEFT IN PLACE FOR LONG PERIODS. IN ADDITION, FLUSHING SHOULD NOT RESULT IN SWALLOWING OR INHALING IF DONE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33136 BLEEDARREST NASAL STRIP TOPICAL HEMOSTAT FRO HEMOSTASIS, LLC. BACP1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other