BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARLEX

    MDR report key: 1338223 · Received March 5, 2009

    Report

    Report Number
    MW5010234
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 21, 2009
    Report Date
    March 5, 2009
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT PROBLEM WAS THE PATCH/PLUG. A MARLEX PATCH SEEMS TO HAVE BROKEN OR MALFUNCTIONED JUST AROUND TWO MONTHS AFTER MY LEFT INGUINAL HERNIA SURGERY CONDUCTED IN LATE 2008. I HAVE BEEN EXPERIENCING EXTREMELY PAINFUL EPISODES OF ABDOMINAL PAIN IN AND AROUND THE PATCH AREA. IT SEEMS AS THOUGH THE PATCH HAS BROKEN FREE AND IS MOVING AROUND. THIS HAS LED TO THROBBING AND A DEEP AND STRONG DISCOMFORT AROUND THE AREA OF THE SURGERY. IT FEELS AS IF I AM BACK AT 10-18 DAYS IN THE RECOVERY AGAIN, WHICH WAS STILL IN THE PAINFUL ZONE. I HAVE READ ABOUT MANY OF THESE PATCHES BECOMING DEFECTIVE AND IT SEEMS THAT THIS ONE IS INCLUDED. I FELT THE "RING" SEEMED TO BREAK FREE IN AN ALARMING SNAP, OR SHARP RELEASING SENSATION. FROM THIS POINT FORWARD, THERE HAS BEEN CONSIDERABLE DISCOMFORT. I HAVE BEEN HELD AWAKE AT NIGHT AND WOKEN FROM A DEAD SLEEP FROM THE PAIN. DIAGNOSIS OR REASON FOR USE: LEFT INGUINAL HERNIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX PATCH OR PLUG FTL DAVOL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other