BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELKER EMERGENCY CUFFED SPECIAL OPERATIONS CRICOTHYROTOY CATHETER SET

    MDR report key: 3999532 · Received August 1, 2014

    Report

    Report Number
    1820334-2014-00350
    Event Type
    Death
    Date Received
    August 1, 2014
    Report Date
    July 16, 2014
    Manufacturer
    COOK INC
    Product Code
    BWC
    PMA / PMN Number
    K010016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH UNK. DEVICE CODE - IT APPEARS THERE WAS NOTHING WRONG WITH THE SUPPLIED SCALPEL BUT THAT IT WAS NOT LONG ENOUGH TO SEE ON AN OBESE PT. NO MENTION OF PT SIZE IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    DURING A CRICOTHYROTOMY ON A LARGE (OVERWEIGHT) PT, THE INCLUDED DISPOSABLE SCALPEL WAS TOO SMALL TO CUT THROUGH ALL OF THE TISSUE IN ORDER TO CREATE AN AIRWAY. THE PT EXPIRED. THE USER FACILITY IS NOT CLAIMING THE DEVICE IS AT FAULT FOR THE PT OUTCOME. HOWEVER, IT WAS RECOMMENDED THAT A LARGER SCALPEL BE INCLUDED, TO ACCOMMODATE ALL TYPE OF PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449546 MELKER EMERGENCY CUFFED SPECIAL OPERATIONS CRICOTHYROTOY CATHETER SET BWC NEEDLE, EMERGENCY AIRWAY BWC COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death