BEUDAMED
    FDA Adverse Event Death Summary report: N

    VAC THERAPY SYSTEM

    MDR report key: 2602685 · Received May 22, 2012

    Report

    Report Number
    1625774-2012-00045
    Event Type
    Death
    Date Received
    May 22, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02/08/2012, THE UNIT PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS PRIOR TO PT PLACEMENT. ON (B)(4) 2012, POST PLACEMENT, THE UNIT PASSED QC CHECKS AND MET SPECIFICATIONS.

    Description of Event or Problem · 1

    FROM NEW (B)(4) THE FOLLOWING WAS REPORTED TO KCI BY THE KCI REP: ON (B)(6) 2012, THE PT WAS FOUND DECEASED. THE VAC THERAPY SYSTEM HAD BEEN TURNED OFF. THE CASE WAS REFERRED TO THE (B)(4) OFFICE TO DETERMINE THE CAUSE OF DEATH. AS OF THIS DATE, KCI HAS YET TO RECEIVE INFO FROM THE HEALTHCARE PROVIDER REGARDING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death