BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C.

    MDR report key: 2924581 · Received January 17, 2013

    Report

    Report Number
    2924581
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    November 2, 2012
    Report Date
    January 17, 2013
    Manufacturer
    KCI USA INC
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD NUMEROUS WOUND VACUUM ASSISTED CLOSURE (VAC) DRESSING CHANGES. THE WOUND HEALED SEVERAL TIMES, BUT BECAME INFECTED REQUIRING CLEANING AND ANTIBIOTICS. THE STAFF DISCOVERED A RETAINED SPONGE USED TO PACK THE WOUND WHICH WAS VERY DEEP WITH A NARROW OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26928 V.A.C. NEGATIVE PRESSURE WOUND THERAPY OMP KCI USA INC * *
    26929 V.A.C. NEGATIVE PRESSURE WOUND THERAPY OMP KCI USA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R OTHER