BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORETEX OVERLAY

    MDR report key: 826664 · Received March 5, 2007

    Report

    Report Number
    MW1042121
    Event Type
    Death
    Date Received
    March 5, 2007
    Date of Event
    February 20, 2007
    Report Date
    March 5, 2007
    Manufacturer
    WL GORE
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS RESTRAINED IN BED AS A FALL PRECAUTION; DURING RESTRAINT/FALL ROUNDS, PRIMARY CARE NURSE DISCOVERED PT BETWEEN THE SIDE RAIL, BUTTOCKS AND EXTENDED LEGS ON THE FLOOR. HER BACK WAS AGAINST THE BED, VEST RESTRAINTS IN PLACE AROUND TORSO (STRAPS INTACT). GORTEX OVER LAY IN USE (1ST STEP), HILLROM CENTURY CC BED, DE ROYAL SLEEVED VEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORETEX OVERLAY * FNM WL GORE * *
    2 CENTURY CC BED * FNL HILL-ROM * *
    3 DEROYAL SLEEVED VEST * FMQ DEROYAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death