BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VESICA SLING KIT WITH PROTEGEN

    MDR report key: 220003 · Received April 21, 1999

    Report

    Report Number
    220003
    Event Type
    Injury
    Date Received
    April 21, 1999
    Date of Event
    February 20, 1999
    Report Date
    March 11, 1999
    Manufacturer
    MICROVASIVE UROLOGY, BOSTON SCIENTIFIC CORP.
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VAGINAL EROSION AND SUPRAPUBIC BONE INFECTION REQUIRED REMOVAL OF SLING, SUTURES AND BONE SCREWS. DEVICE VOLUNTARILY RECALLED ON LETTER DATED 1/22/1999.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VESICA SLING KIT WITH PROTEGEN Implant FEMALE INCONTINENCE URETHRAL SLING FTL MICROVASIVE UROLOGY, BOSTON SCIENTIFIC CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention