BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEXTURED SALINE-FILL MAMMARY IMPLANT

    MDR report key: 16265 · Received September 20, 1994

    Report

    Report Number
    MW1003450
    Event Type
    Injury
    Date Received
    September 20, 1994
    Date of Event
    October 13, 1992
    Report Date
    September 16, 1994
    Manufacturer
    UNKNOWN
    Product Code
    FWM
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DUE TO SCARRING, RPTR HAD CAPSULOTOMY IMPLANT REPLACEMENT. THIS TIME, A SALINE IMPLANT WAS USED. AT THIS TIME, SHE IS EXPERIENCING A HARDENING IN HER RIGHT BREAST AND FEELS AS IF THERE IS A TIGHT BAND AROUND HER CHEST THIS CAUSES A FEELING OF SOME PRESSURE WHEN SHE BREATHES. (SAME RPTR REFERRED TO IN 1003448 AND 1003449.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEXTURED SALINE-FILL MAMMARY IMPLANT Implant TEXTURED SALINE IMPLANT FWM UNKNOWN NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization