BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 979807 · Received December 28, 2007

    Report

    Report Number
    1213643-2007-01030
    Event Type
    Injury
    Date Received
    December 28, 2007
    Date of Event
    March 16, 2007
    Report Date
    December 4, 2007
    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 Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 RETURNED FOR EVAL OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT REPORTED THAT IN 2005 HE HAD A REPAIR FOR A LEFT INGUINAL HERNIA, DURING SURGERY IT WAS DETERMINED THAT THERE WAS NO DIRECT OR INDIRECT HERNIA, BUT THE OPERATION WAS PERFORMED ANYWAY. REPAIR WAS DONE WITH PERFIX PLUG SYSTEM. HE HAS HAD DISABLING PAIN EVER SINCE. HE WAS TOLD THE NERVE IS ENTRAPPED IN THE MESH. IN 2007, PT HAD ANOTHER SURGERY BECAUSE OF THE PAIN STILL ASSOCIATED WITH THE FIRST OPERATION AND INGUINAL NERVE ENTRAPPED IN THE MESH. MESH AND PLUG WAS NOT REMOVED DURING THE SECOND OPERATION, ONLY NEURECTOMY PERFORMED ILIO INGUINAL NERVE AND ITS BRANCHES CUT AND TIED. PT REPORTS HE HAS BEEN IN DISABLING PAIND SINCE AFTER THE SECOND OPERATION. NOW HAVING A THIRD OPERATION TO REMOVE MESH AND PLUG APPROX SEVEN AND A HALF MONTHS LATER. THIRD SURGEON STATED THAT THE PLUG IS PROBABLY CIRCLED AND WRAPPED AROUND THE SPERMATIC CORD OR HAS ENTRAPPED NERVES, WHICH IS THE CAUSE OF THE PAIN. PT HAD BEEN IN PAIN MGMT SINCE FOUR MONTHS EARLIER. PT HAS HAD SIX SERIES OF NERVE BLOCK, ALL HAVE DONE NOTHING. PT'S SYMPTOMS INCLUDE AND ARE NOT LINITED TO" EXTREME PAIN IN TESTICLES, BURNING, PINCHING, STABBING PAIN THROUGHOUT THE ENTIRE GROIN, BURNING PAIN IN UPPER AND INSIDE THIGH, EXTREME PRESSURE THROUGHOUT GROIN AREA, EXTREME BLOATING, CONSTIPATION AND BRIGHT RED BLOOD IN STOOLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HPD066

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R| S