BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERNIA MESH

    MDR report key: 6131591 · Received November 25, 2016

    Report

    Report Number
    MW5066375
    Event Type
    Injury
    Date Received
    November 25, 2016
    Date of Event
    May 20, 2016
    Report Date
    November 25, 2016
    Manufacturer
    UNK
    Product Code
    OWT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    MY (B)(6) YEAR OLD FATHER HAD A HERNIA OPERATION IN (B)(6), CT LASTED LONGER THAN EXPECTED... REPAIRED WITH HERNIA MESH... IMMEDIATELY EXPRESSED DISCOMFORT. FEELS PULLING IN AREA OF THE MESH... SOMETIMES THE PAIN IS SO INTENSE HE IS REDUCED TO TEARS... CANNOT TOLERATE ANY PRESSURE AROUND HIS WAIST...BELT TO HOLD PANTS IS UNCOMFORTABLE AND CANNOT SLEEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778197 HERNIA MESH HERNIA MESH OWT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Disability DO NOT KNOW WHAT THEY ARE. | RX MEDS: MY FATHER TAKES 5 PILLS EACH DAY.