BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY

    MDR report key: 3093810 · Received April 30, 2013

    Report

    Report Number
    3009897021-2013-00036
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO V.A.C. THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADD'L INFO, BUT THERE HAS BEEN NO RESPONSE. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE. ON (B)(4) 2013, KCI FIELD SERVICE TESTED THE DEVICE PER QUALITY CONTROL (QC) PROCEDURE AND DETERMINED THE UNIT MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT ON (B)(4) 2013. THE DEVICE WAS RETURNED TO KCI FOR EVAL. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING INFO WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2013, THE PATIENT WAS ADMITTED (FACILITY UNK), AND ALLEGED THE WOUND GOT INFECTED WHILE ON V.A.C THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187530 V.A.C. THERAPY OMP KCI USA INC. ACTIV.A.C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R