BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PATCH AND PLUG FOR HERNIA

    MDR report key: 2883914 · Received December 19, 2012

    Report

    Report Number
    MW5028241
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    July 27, 2005
    Report Date
    December 19, 2012
    Manufacturer
    BARD
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT HAD BARD PERFIX PATCH AND PLUG PROCEDURE FOR HERNIA IN 2005. FOR THE PAST TWO MONTHS SHE HAS SUFFERED EXTREME PAIN FROM THE DEVICE. SHE HAS SEEN DOCTORS WHO SAID SHE MIGHT LOSE HER LIFE IF THEY TRY TO EXPLANT THE DEVICE. PER THE CALLER, PATCH APPEARS DEFECTIVE AND ROUGH AROUND EDGES. THE PATCH IS HARDENED AROUND HER NERVE WHICH CAUSES THE PAIN. CT SCAN REVEAL THAT THE PATCH HAS MIGRATED. FLUID AND GEL LIKE SUBSTANCE WAS PRODUCED AROUND THE PATCH AND EXTRACTED BY THE DOCTOR WHO ADVISED, THERE IS A RISK OF LOSS OF LIFE IF EXPLANTED. CALLER IS PT'S FATHER WHO RECOMMEND THIS DEVICE BE RECALLED. HE SAID THE DEVICE IS SIMILAR TO KUGEL RECALL BY THE SAME MFR, BARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PATCH AND PLUG FOR HERNIA PERFIX PATCH AND PLUG FOR HERNIA FTL BARD

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR