BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGIWRAP

    MDR report key: 9671971 · Received February 5, 2020

    Report

    Report Number
    3004661493-2018-00001
    Event Type
    Injury
    Date Received
    February 5, 2020
    Date of Event
    July 11, 2015
    Report Date
    February 4, 2020
    Manufacturer
    MAST BIOSURGERY USA INC
    Product Code
    FTL
    PMA / PMN Number
    K050332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    UROLOGICAL SURGEON USED THE SURGIWRAP DURING SURGERY AND AFTER SOME TIME, THE SURGEON WITNESSED INFECTION WHEN HE OPENED UP THE SITE FOR ANOTHER PURPOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136624 SURGIWRAP MESH, SURGICAL, POLYMERIC FTL MAST BIOSURGERY USA INC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other