BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 371556 · Received January 8, 2002

    Report

    Report Number
    MW1023824
    Event Type
    Malfunction
    Date Received
    January 8, 2002
    Date of Event
    December 26, 2001
    Report Date
    January 8, 2002
    Manufacturer
    NA
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN FOR CONSULTATION. SUPERIOR DISPLACEMENT OF GEL IMPLANTS. SURGERY TO REMOVE AND REPLACE WITH GEL. PARTIAL CAPSULECTOMIES. LEFT EXPLANT INTACT. RIGHT EXPLANT RUPTURE WITH SHELL IN PIECES. REPLACED WITH GEL IMPLANTS. PARTIAL CAPSULECTOMIES. BILATERALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NA GEL BREAST IMPLANTS FTR NA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR