BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY UNIT

    MDR report key: 3410352 · Received October 8, 2013

    Report

    Report Number
    MW5032230
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    September 18, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GENADYNE BIOTECH, INC
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, BIOLOGIC WASTE WAS DISCOVERED IN THE INTERNAL MECHANISM OF TWO GENADYNE WOUND THERAPY UNITS. THESE WOUND THERAPY UNITS PROVIDE SUCTION TO CREATE NEGATIVE PRESSURE FOR A WOUND THERAPY TECHNIQUE CURRENTLY REFERRED TO A "WOUND VAC". THESE UNITS WERE TAKEN OUT OF SVC ON THE DATES INDICATED ABOVE. THE VENDOR, GENADYNE BIOTECH, INC. WAS NOTIFIED OF THIS ISSUE ON (B)(4) 2013. DIAGNOSIS OR REASON FOR USE: THERAPY TO PROMOTE WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508357 GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY UNIT A4 GENADYNE WOUND VAC OMP GENADYNE BIOTECH, INC A4
    508358 GENADYNE A4 NEGATIVE PRESSURE WOUND THERAPY UNIT A4 GENADYNE WOUND VAC OMP GENADYNE BIOTECH, INC A4
    508359 GENADYNE COLLECTION CANISTER GENADYNE COLLECTION CANISTER OMP GENADYNE BIOTECH, INC A4-S00C3A

    Patients

    Seq Age Sex Outcome Treatment
    1