BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-ARC

    MDR report key: 2423159 · Received January 13, 2012

    Report

    Report Number
    MW5023830
    Event Type
    Injury
    Date Received
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    AMS
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I DEVELOPED AN ANTERIOR VAGINAL WALL EROSION SECONDARY TO A MINI-ARC THAT WAS IMPLANTED INTO ME ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-ARC MINI-ARC FTL AMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| S