BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KCI PREVENA 125 THERAPY UNIT

    MDR report key: 19340014 · Received May 16, 2024

    Report

    Report Number
    MW5155028
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 9, 2024
    Manufacturer
    KCI USA, INC.
    Product Code
    QFC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PREVENA THERAPY UNIT/CANISTER NOT WORKING PROPERLY. CONTINUOUSLY MAKING NOISE AND NOT VACUUMING PROPERLY. WOULD NOT TURN OFF DESPITE HOLDING DOWN POWER BUTTON AND DISASSEMBLING CARTRIDGE. WOULD ONLY TURN OFF WHEN REMOVING BATTERIES. REFERENCE REPORT: MW5155029.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615026 KCI PREVENA 125 THERAPY UNIT NEGATIVE PRESSURE WOUND THERAPY DEVICE FOR REDUCTION OF WOUND COMPLICATIONS QFC KCI USA, INC. C12820

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female