BEUDAMED
    FDA Adverse Event Summary report: N

    BARD MESH PERFIX PLUG

    MDR report key: 7230508 · Received January 30, 2018

    Report

    Report Number
    MW5074967
    Date Received
    January 30, 2018
    Date of Event
    August 9, 2012
    Report Date
    January 10, 2018
    Manufacturer
    BARD DAVOL, INC.
    Product Code
    FTL
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2012, (B)(6), I OBTAINED A HERNIA SURGERY AND AT THIS POINT BARD MESH PERFIX PLUG; REF 0112770; SIZE: LARGE PLUGL LOT: HUWA0655 WAS IMPLANTED. WITHIN MONTHS THE HERNIA RETURNED CAUSING PAIN AND CONSTIPATION. AT THIS POINT I WAS PLACED ON PAIN MEDICATION AND STOOL SOFTENER (COLACE). IN 2013, I WAS GIVEN A HERNIA BELT. I DID NOT OBTAIN A CORRECTIVE HERNIA SURGERY UNTIL (B)(6) 2016. ON MY SECOND HERNIA SURGERY ON (B)(6) 2016 I OBTAINED ANOTHER COMPLICATION. I AM CURRENTLY ON MEDICATION FOR NERVE PAIN BECAUSE IN THE PROCESS OF MY SECOND HERNIA SURGERY A NERVE WAS CUT/PINCHED, WHICH IS AN ISSUE THAT I WILL NOW FOREVER HAVE. NOTE: IN 2016 I HAD TO GET ANOTHER HERNIA REPAIR TO CORRECT THE PREVIOUS ONE AT (B)(6). THE HERNIA REPAIR WAS DONE BY (B)(6). WHY WAS THE PERSON USING THE PRODUCT: HERNIA REPAIR (LEFT INGUINAL HERNIA REPAIR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73311 BARD MESH PERFIX PLUG MESH SURGICAL FTL BARD DAVOL, INC. HUWA0655

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR