BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRIMMS - PLASTI - LINER

    MDR report key: 1610543 · Received February 17, 2010

    Report

    Report Number
    MW5014808
    Event Type
    Other
    Date Received
    February 17, 2010
    Date of Event
    March 1, 1996
    Report Date
    January 31, 2010
    Manufacturer
    COMBE INCORPORATED
    Product Code
    KOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USED PLASTIC LINER SINCE (B) (6) 1996, TO PRESENT TIME. STILL USING, WHILE I WAS USING THIS I LIVED IN (B) (6) FOR 10 YEARS. MY LEGS WOULD TINGLE AND PAIN. I HAD ULTRA SOUNDS OF MY LEGS AND THEY COULD NOT FIND ANYTHING. I STILL HAVE PROBLEMS TO THIS DAY WITH MY LEGS. HAVE TRIED DIFFERENT TIMES BUT NOTHING HAS BEEN DONE. THEY HURT ME EVERY NIGHT THAT I CAN HARDLY SLEEP WITH THEM. DOSE OR AMOUNT: PLASTI-LINER. FREQUENCY: 2 MONTHS. ROUTE: ORAL. DATES OF USE: (B) (6) 1996 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: USED AS A RELINER. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIMMS - PLASTI - LINER SOFT LIKE FIXODENT KOL COMBE INCORPORATED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other