BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL MESH

    MDR report key: 2802798 · Received October 23, 2012

    Report

    Report Number
    MW5027284
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 12, 2004
    Report Date
    October 23, 2012
    Product Code
    FTL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH SURGICAL MESH IN (B)(6) 2004. IN (B)(6) 2011, HE BEGAN EXPERIENCING SEVERE PAIN IN HIS INGUINAL REGION, TESTICLES, PAINFUL URINATION, PAINFUL EJACULATION, PAINFUL BOWEL MOVEMENT AND PAINFUL AMBULATION. HE CAN NOT PERFORM ANY KIND OF ACTIVITY AND IS NOW DISABLED. HE HAS HAD CRYOABLATION PROCEDURE DONE AROUND THE INGUINAL AREA AND IS PRESENTLY ON LOTS OF PAIN MEDICATIONS. HE HAS NOT BEEN ABLE TO FIND A SURGEON WHO IS WILLING TO EXPLANT THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL MESH MESH FTL D3E439
    2 SURGICAL MESH MESH FTL D3K1008

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R| S