BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENA PEEL PLACE

    MDR report key: 11669214 · Received April 15, 2021

    Report

    Report Number
    11669214
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 8, 2021
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NARRATIVE FROM STAFF: DURING THE CASE, A PREVENA INCISION MANAGEMENT SYSTEM WAS REQUESTED FOR THE CASE. THE RN IN THE ROOM OPENED THE ITEM AND NOTED THAT THE SEAL ON THE INNER PACKAGING WAS NOT SEALED AT ALL. THIS MAKES THIS ITEM UNSTERILE. THE RN IN THE ROOM DID NOT USE THE ITEM AND ANOTHER ITEM WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569356 PREVENA PEEL PLACE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP KCI USA, INC. PRE1001US 8734909V004

    Patients

    Seq Age Sex Outcome Treatment
    1