BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIV.A.C. THERAPY

    MDR report key: 4245037 · Received November 6, 2014

    Report

    Report Number
    3009897021-2014-00134
    Event Type
    Death
    Date Received
    November 6, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 8, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE PATIENT EXPIRING IS RELATED TO V.A.C. THERAPY. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE PATIENT HAS EXPIRED. ON (B)(4) 2014, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S FAMILY MEMBER: THE PATIENT EXPIRED ON (B)(6) 2014. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(4) 2014, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2014, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(4) 2014, IT WAS DETERMINED BY KCI QUALITY ENGINEERING THAT THREE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE, THEREFORE KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714251 ACTIV.A.C. THERAPY OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death