BEUDAMED
    FDA Adverse Event Summary report: N

    SILTEX LOW BLEED GEL-MAMMARY PROSTHESIS, 400 CCS

    MDR report key: 16017 · Received September 12, 1994

    Report

    Report Number
    MW1003313
    Date Received
    September 12, 1994
    Report Date
    September 12, 1994
    Manufacturer
    MENTOR CORP.
    Product Code
    FTR
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RTPR WAS SEEN BY DR ON 7/30/91 WITH A ONE YR HISTORY OF PARESTHESIAS OF THE RIGHT AND LEFT HAND WITH NOCTURNAL PARESTHESIAS AND SOME REDUCTION IN GRIP. THIS HAS INCREASED IN THE PAST SEVERAL MONTHS. TWO WEEKS AGO THE PT BEGAN USING WRIST SPLINTS WHICH HAVE RESULTED IN NO SIGNIFICANT CHANGE IN HER SYMPTOMS. ANTI-INFLAMMATORIES HAVE BEEN OF NO HELP, ALSO. TRIGGER FINGERS OF BOTH HANDS, ALL FINGERS, CARPEL TUNNEL SYNDROME BOTH WRISTS AND ARTHRITIS STARTING IN BOTH HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILTEX LOW BLEED GEL-MAMMARY PROSTHESIS, 400 CCS Implant GEL-MAMMARY PROSTHESIS FTR MENTOR CORP. 29852/RT, 29854/LT

    Patients

    Seq Age Sex Outcome Treatment
    1 *