BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2251329 · Received September 13, 2011

    Report

    Report Number
    1625774-2011-00112
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN FURTHER MEDICAL INFO. ON (B)(6) 2011, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURES BY KCI FIELD SERVICE, AND THE UNIT PASSED QC CHECKS AND MET SPECS. ON (B)(6) 2011, THE DEVICE WAS RECEIVED FOR EVAL. INSPECTION, TESTING AND EVAL OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION OR DEFECT WITH THE DEVICE. THE DEVICE FUNCTIONED AS INTENDED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO KCI BY THE PT'S SPOUSE: ON (B)(6) 2011, V.A.C. THERAPY WAS INITIATED. ON AN UNK DATE, THE DOCTOR FOUND AN INFECTION IN THE PT'S DEHISCED ABDOMINAL WOUND AND IT WAS ALLEGED THAT V.A.C. THERAPY WAS NOT WORKING. ON (B)(6) 2011, THE PT WAS ADMITTED TO THE HOSP WITH A WOUND INFECTION. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM OMP KCI USA, INC. ACTIV.A.C. THERAPY

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R JEVITY FEEDING