BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WINCO MFG, LLC

    MDR report key: 3057232 · Received April 8, 2013

    Report

    Report Number
    MW5029716
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 20, 2012
    Report Date
    April 8, 2013
    Manufacturer
    WINCO MFG, LLC
    Product Code
    FRJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WINCO MFG, LLC PROVIDED CLINICAL RECLINER CHAIRS. THE CHAIRS ARE LESS THEN 6 MONTHS OLD AND ARE MECHANICALLY BREAKING. IN THE SCISSOR MECHANISMS, THE SCREWS ARE FALLING OUT ALLOWING THE CHAIRS TO LOCK INTO A RECLINE POSITION AND WILL NOT ALLOW PTS TO SIT UP RIGHT. DANGER IN LOW BLOOD PRESSURE, RESTRAINT FROM EXISTING CHAIR AND MECHANICALLY UNSTABLE. DATES OF USE: (B)(6) 2012 - (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144247 WINCO MFG, LLC RECLINER CHAIR, 300# FRJ WINCO MFG, LLC VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1