BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR

    MDR report key: 75984 · Received January 22, 1997

    Report

    Report Number
    75984
    Event Type
    Malfunction
    Date Received
    January 22, 1997
    Date of Event
    July 1, 1996
    Report Date
    July 3, 1996
    Manufacturer
    MENTOR HS, INC.
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 7/1/96 PT NOTICED A CHANGE IN LEFT BREAST. PT DESCRIBED HER FINDINGS AS "A DISHED OUT SECTION AND A LUMP ON INNER SIDE OF BREAST, FELT LIKE IT WAS FOLDED ON SELF." PT NOTIFIED HER PHYSICIAN 7/2/96 AND 7/3/96 SHE HAD SURGERY FOR EXCHANGE OF RUPTURED LEFT BREAST IMPLANT WITH SALINE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR Implant SALINE BREAST IMPLANT FWM MENTOR HS, INC. * 86412

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other