BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH-COMPOSIX KUGEL

    MDR report key: 1212104 · Received October 24, 2008

    Report

    Report Number
    1213643-2008-00469
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    March 7, 2007
    Report Date
    September 29, 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
    ATTORNEY

    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 EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2007- PATIENT HAD AN INCISIONAL HERNIA REPAIR PERFORMED. COMPOSIX KUGEL PATCH WAS IMPLANTED DURING THIS PROCEDURE. ON A WEEK LATER- PATIENT WAS ADMITTED TO THE HOSPITAL WITH FEVER AND ABDOMINAL PAIN. SHE WAS FOUND TO HAVE INCREASED SEROSANGUINEOUS DRAINAGE FROM HER WOUND SITE. ON FOUR DAYS LATER - PATIENT UNDERWENT DEBRIDEMENT AND IRRIGATION OF THE WOUND AND PICC LINE PLACEMENT FOR IV ANTIBIOTICS. ON THE NEXT DAY - PATIENT WAS SEEN BY DOCTOR FOR A WOUND CONSULTATION. DOCTOR'S IMPRESSION WAS "FAT NECROSIS/INFECTION OF INCISIONAL HERNIA REPAIR WOUND. APPARENTLY, THERE WAS NO GROSS PUS SEEN ON THE SURGICAL DEBRIDEMENT. HOWEVER, WOUND CULTURES ARE SHOWING GROWTH OF ANAEROBIC ORGANISMS". DOCTOR PRESCRIBED TYGACIL FOR FOUR WEEKS. ON TWO DAYS LATER - PATIENT WAS DISCHARGED HOME WITH THE PICC LINE FOR IV ANTIBIOTIC THERAPY AND HOME HEALTH. ON THE FOLLOWING MONTH - PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN INFECTED ABDOMINAL WALL ABSCESS. PATIENT UNDERWENT A CT SCAN GUIDED ABDOMEN ABSCESS DRAINAGE ON THIS DATE. THE ASPIRATION OBTAINED FLUID WITH THE APPEARANCE OF "FRANK PUS." AFTER THE DRAINAGE REVEALED PURULENT MATERIAL, IT WAS ELECTED TO REMOVE THE INFECTED MESH AND TO DO SURGICAL DEBRIDEMENT. ON TWO DAYS LATER - PATIENT UNDERWENT REMOVAL OF INFECTED MESH. IT WAS NOTED ON THE OPERATIVE REPORT THAT "THE MESH WAS ACTUALLY FIXED ON ITS ANTERIOR SURFACE BENEATH THE MUSCLE CIRCUMFERENTIALLY. HOWEVER, THE AREA FRIGHT UNDER THE WOULD WAS NOT FIXED." THE ENTIRE MESH WAS REMOVED AND A BIOLOGIC MESH WAS LAID BACK IN PLACE."... A LARGE SUCTION DRAIN WAS PLACED IN THE SPACE UNDER THIS MESH. AFTER COMPLETING THE REPAIR, ANOTHER LARGE SUCTION DRAIN WAS PLACED AT TOP OF THE MESH." ... IRRIGATION WAS PERFORMED WITH ANTIBIOTIC SOLUTION..." ON FOUR DAYS LATER - PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH HOME HEALTH FOR PICC LINE CARE, IV ANTIBIOTICS AND PHYSICAL THERAPY FOR DECONDITIONING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R