BEUDAMED
    FDA Adverse Event Other Summary report: N

    NI

    MDR report key: 66027 · Received January 2, 1997

    Report

    Report Number
    66027
    Event Type
    Other
    Date Received
    January 2, 1997
    Date of Event
    October 28, 1996
    Report Date
    November 21, 1996
    Manufacturer
    NI
    Product Code
    FTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNDERWENT EXPLANTATION OF RIGHT BREAST IMPLANT ND CAPSULE. PROSTHESES WAS DEFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI Implant SILICONE GEL-FILLED BREAST PROSTHESIS FTR NI NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other