BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.R. BARD/ DAVOL MARLEX PART NUMBERS 0112650, 0112660, 0112680

    MDR report key: 7525404 · Received May 17, 2018

    Report

    Report Number
    MW5077291
    Event Type
    Injury
    Date Received
    May 17, 2018
    Report Date
    May 16, 2018
    Manufacturer
    CR BARD/ DAVOL
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD HERNIA SURGERY IN 2006 AND HAVE OVER THE YEARS HAD PAIN IN MY GROIN, ABDOMEN AND BACKSIDE AREA. I WAS NOT NOTIFIED BY THE MANUFACTURER, DOCTORS OR HOSPITAL OF COMPLICATIONS I MAY HAVE DUE TO THE MESH PLACED INSIDE OF ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366641 C.R. BARD/ DAVOL MARLEX PART NUMBERS 0112650, 0112660, 0112680 MESH FTL CR BARD/ DAVOL
    366642 C.R. BARD/ DAVOL MARLEX PART NUMBERS 0112650, 0112660, 0112680 MESH FTL CR BARD/ DAVOL
    366643 C.R. BARD/ DAVOL MARLEX PART NUMBERS 0112650, 0112660, 0112680 MESH FTL CR BARD/ DAVOL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| L| O| R| S