BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIV.A.C. THERAPY

    MDR report key: 4855470 · Received June 18, 2015

    Report

    Report Number
    3009897021-2015-00045
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 23, 2015
    Report Date
    August 27, 2015
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT WAS CORRECTED FROM (B)(6). PMA/510(K)# K063692 WAS INCLUDED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE NURSE ALLEGEDLY OBSERVED BLOOD "LEAKING OUT" OF THE PATIENT'S COCCYX WOUND. ON 05/27/2015, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: ON (B)(6) 2015, THE PATIENT WENT TO THE HOSPITAL AND UNDERWENT CAUTERIZATION FOR THE HEMORRHAGE. THE PATIENT REPORTED EXPERIENCING LIGHTHEADNESS BUT CONFIRMED HE DID NOT RECEIVE A BLOOD TRANSFUSION. V.A.C. THERAPY WAS RE-APPLIED AND HE HAS NOT HAD ANY SUBSEQUENT ISSUES. NO ADDITIONAL INFORMATION IS AVAILABLE. ON (B)(6) 2015, 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) 2015, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2015, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI QUALITY ENGINEERING, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. NO FAULT WAS FOUND WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396473 ACTIV.A.C. THERAPY OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 110 YR Hospitalization| R