BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX MESH

    MDR report key: 1032991 · Received April 11, 2008

    Report

    Report Number
    1213643-2008-00259
    Event Type
    Injury
    Date Received
    April 11, 2008
    Report Date
    April 8, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    preamendment
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO INITIAL RPTR CONTACT INFO INCLUDED ON THE MAUDE REPORT, THEREFORE, NO F/U CAN BE MADE. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE. MAUDE REPORT LISTED THREE DEVICES - REFERENCE MDRS 1213643-2008-00257 & 1213643-2008-00258 FOR INFO RELATED TO THE OTHER TWO DEVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER THAT HE HAS ONGOING PROBLEMS, FISTULAE, INFECTIONS, NO ABDOMINAL WALL SINCE BEING IMPLANTED. HE ALSO REPORTS OPEN WOUNDS AND SKIN GRAFTS THAT HAVE NOT TAKEN DUE TO "MESH BREAKING THROUGH THE SKIN GRAFTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX MESH FTL FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HMD020

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| R AND CONTINUES TO CUT AND REMOVE MESH FROM| HIS OPEN WOUNDS.| REPORTED THAT PT'S WIFE TREATS WOUNDS DAILY