BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIV.A.C. THERAPY

    MDR report key: 4307547 · Received December 2, 2014

    Report

    Report Number
    3009897021-2014-00148
    Event Type
    Death
    Date Received
    December 2, 2014
    Report Date
    November 3, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHEN THE EVENT OCCURRED AS THIS INFORMATION HAS NOT BEEN PROVIDED. 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 RELATED TO THE EVENT, BUT THERE HAS BEEN NO RESPONSE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: A PATIENT HAD A PROSTHESIS REMOVED AND V.A.C. THERAPY WAS APPLIED. NO BLOOD WAS OBSERVED IN THE CANISTER NOR DID THE PATIENT EXPERIENCE ANY ALARM CONDITIONS. "A FEW DAYS LATER, THERE WAS A MASSIVE BLEED AND FOAM AND EVERYTHING WAS PUSHED OFF THE STUMP WOUND." THE PATIENT SUBSEQUENTLY EXPIRED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ON (B)(6) 2014, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE ((B)(4)), AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2014, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2014, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE ((B)(4)), AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777841 ACTIV.A.C. THERAPY OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death