BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSTOMIZABLE PREVENA¿ INCISION DRESSING

    MDR report key: 6048181 · Received October 21, 2016

    Report

    Report Number
    3009897021-2016-00091
    Event Type
    Injury
    Date Received
    October 21, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 21, 2016
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K123878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED "POOR TISSUE FORMATION" AND NECROTIC TISSUE AT THE WOUND SITE ARE RELATED TO THE CUSTOMIZABLE PREVENA¿ INCISION DRESSING. THERE HAVE BEEN SEVERAL ATTEMPTS MADE TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: THERAPY SHOULD BE CONTINUOUS FOR A MINIMUM OF 2 DAYS UP TO A MAXIMUM OF 7 DAYS. PATIENTS SHOULD BE INSTRUCTED NOT TO TURN THERAPY OFF UNLESS: ADVISED BY THE TREATING PHYSICIAN. BLEEDING DEVELOPS SUDDENLY OR IN LARGE AMOUNTS DURING THERAPY. THERE ARE SERIOUS SIGNS OF ALLERGIC REACTION OR INFECTION. THE CANISTER IS FULL OF FLUID. BATTERIES NEED TO BE CHANGED. SYSTEM ALERTS MUST BE ADDRESSED. PATIENT SHOULD BE INSTRUCTED TO CONTACT THE TREATING PHYSICIAN IF: BLEEDING DEVELOPS. SIGNS OF INFECTION ARE PRESENT. THERAPY UNIT TURNS OFF AND CANNOT BE RESTARTED BEFORE THERAPY IS SCHEDULED TO END. INDICATOR AND ALERT SYMBOLS: THE THERAPY UNIT WILL PROVIDE AUDIBLE AND VISUAL ALERTS. IF ALERT CONDITIONS CANNOT BE CORRECTED, PATIENT SHOULD CONTACT TREATING PHYSICIAN.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: THE PHYSICIAN REPORTED THAT A CUSTOMIZABLE PREVENA INCISION DRESSING WAS PLACED ON A PATIENT AND UPON REMOVAL OF THE DRESSING THE "TISSUE FORM WAS REALLY BAD." ON (B)(6) 2016, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE KCI REPRESENTATIVE: THE PHYSICIAN REPORTED THAT WHEN THE CUSTOMIZABLE PREVENA INCISION DRESSING WAS REMOVED THEY FOUND NECROTIC TISSUE AT THE WOUND SITE THAT REQUIRED SURGICAL INTERVENTION TO RESOLVE. NO ADDITIONAL INFORMATION WAS PROVIDED. NEITHER THE UNIT'S SERIAL NUMBER NOR THE DRESSING LOT NUMBER WAS PROVIDED; THEREFORE, KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT OR A DEVICE HISTORY REVIEW OF THE DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698571 CUSTOMIZABLE PREVENA¿ INCISION DRESSING OMP OMP KCI USA, INC. WNDPRV

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention