BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1150558 · Received September 4, 2008

    Report

    Report Number
    1213643-2008-00419
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    November 13, 2007
    Report Date
    August 5, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K003323
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    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. WHILE RECURRENCE IS A KNOWN ADVERSE EVENT THAT IS LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2006 - THE PT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR WITH A COMPOSIX KUGEL MESH. ABOUT ONE YEAR AFTER THE IMPLANT SURGERY, PT BEGAN EXPERIENCING LEFT LOWER ABDOMINAL PAIN WHICH PROGRESSIVELY GOT WORSE AROUND 2007. IN THE SAME MONTH- THE PT WAS ADMITTED TO THE EMERGENCY ROOM AND WAS EXAMINED FOR ABDOMINAL AND SUPRAPUBIC PAIN. A CT SCAN WAS PERFORMED AND IT REVEALED A RIGHT-SIDED PELVIC MASS AND A LARGE VENTRAL HERNIA. PT WAS SCHEDULED FOR EXPLORATORY LAPAROTOMY SURGERY. THE NEXT DAY - THE PT WAS DISCHARGED FROM THE HOSPITAL IN STABLE CONDITION, ON PAIN MEDICATIONS. THE FOLLOWING MONTH - THE PT UNDERWENT EXPLORATORY LAPAROTOMY SURGERY WITH EXPLANT OF THE MESH. A VENTRAL HERNIA WAS CONFIRMED AND REPAIRED. PT WAS DISCHARGED FROM THE HOSPITAL THREE DAYS LATER. PT'S CONDITION IMPROVED QUICKLY AFTER THE REMOVAL OF THE MESH. IN LATE 2007, PT NOTICED PURULENT DRAINAGE IN THE REGION OF THE REPAIRED HERNIA SITE. THE FOLLOWING YEAR - PT WAS SEEN AT THE HOSPITAL FOR THE PURULENT DRAINAGE. THE AREA WAS PROBED BY HER PHYSICIAN AND OPENED. THE DIAGNOSIS WAS AN INFECTION AND SHE WAS TOLD BY HER PHYSICIAN IF HER INFECTION INCREASED OR WORSENED THAT SHE WOULD BE PRESCRIBED ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43EQD436

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R