BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH - COMPOSIX KUGEL

    MDR report key: 1063462 · Received June 19, 2008

    Report

    Report Number
    1213643-2008-00335
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 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
    BE
    Reporter Occupation
    OTHER

    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 RETURNED FOR EVALUATION OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CT SCAN SHOWING FRAGMENTATION WITH PROTRUSION TOWARDS SKIN, THE PATIENT UNDERWENT A PROCEDURE TO REPLACE THE CURRENT MESH WITH A NEW COMPOSIX KUGEL. IT WAS REPORTED THAT THE RING WAS BROKEN IN SEVERAL FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH - COMPOSIX KUGEL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43LOD249

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention