BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLICON

    MDR report key: 198247 · Received November 17, 1998

    Report

    Report Number
    198247
    Event Type
    Malfunction
    Date Received
    November 17, 1998
    Date of Event
    October 19, 1998
    Report Date
    November 16, 1998
    Manufacturer
    NATURAL SURGICAL SPECIALTIES
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPLACED BILATERAL RUPTURED SILICONE GEL FILLED IMPLANTS ON 10/19/1998. REPLICON MAMMARY PROSTHESIS WAS PLACED ON 4/21/1991.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLICON Implant * FTR NATURAL SURGICAL SPECIALTIES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR