BEUDAMED
    FDA Adverse Event Summary report: N

    SCL MAMMARY PROSTHESIS

    MDR report key: 13483 · Received May 24, 1994

    Report

    Report Number
    MW1002182
    Date Received
    May 24, 1994
    Date of Event
    April 6, 1990
    Report Date
    May 12, 1994
    Manufacturer
    MEDICAL ENGINEERING CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    RPTR COMPLAINS OF HARDENING, RASH, SWELLING, HAIR LOSS, ACHES AND PAINS, LOSS OF SENSATION, INFECTIONS, LOW GRADE FEVERS, AND DRY MOUTH. (SAME RPTR REFERRED TO IN 1002183.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCL MAMMARY PROSTHESIS Implant FTR MEDICAL ENGINEERING CORP. 89199-89L, 89200-89L

    Patients

    Seq Age Sex Outcome Treatment
    1 * *