BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1051418 · Received May 19, 2008

    Report

    Report Number
    1213643-2008-00289
    Event Type
    Injury
    Date Received
    May 19, 2008
    Report Date
    April 22, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURND FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PT THAT HE HAS BEEN EXPERIENCING INCREASING GROIN PAIN FROM A SHIFTING AND HARDENING OF A MESH PATCH THAT WAS USED FOR REPAIR OF A RIGHT INGUINAL HERNIA IN 1998. HE UNDERWENT AN MRI AFTER WHICH PHYSICIAN DETERMINED THAT THE MESH HAD HARDENED AND WADDED UP AND CAUSED THE MESH TO PRESS AGAINST CERTAIN NERVES, THUS CREATING HIS PAIN. HE DESCRIBED THIS CONDITION AS MESHOMA. PT CONTINUES TO HAVE INCREASING PAIN THAT CANNOT BE TREATED WITH TRADITIONAL PAIN MGMT DUE TO AN EXISTING PROBLEM WITH HIS LIVER THAT PROHIBITS THE USE OF MOST PAIN MEDICATION. THIS HAS FORCED HIM TO BE ON DISABILITY DUE TO HIS UNCONTROLLABLE PAIN. IT WAS REPORTED TO BE A PERFIX PLUG AND PATCH POLYPROPYLENE SYSTEM. PHYSICIAN IS HESITANT TO EXPLANT THE PRODUCT DUE TO THE POTENTIAL FOR SERIOUS NERVE DAMAGE. HE HAS DISCUSSED THE POSSIBILITY OF INSERTING ANOTHER MESH ON TOP OR AROUND THE EXISTING PLUG. NO DEFINITE COURSE OF ACTION HAS.......

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability