BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH

    MDR report key: 1033314 · Received April 11, 2008

    Report

    Report Number
    1213643-2008-00257
    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
    K971745
    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 PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO INITIAL REPORTER CONTACT INFO INCLUDED ON THE MAUDE REPORT, THEREFORE NO FOLLOW-UP CAN BE MADE. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR CURRENT KNOWLEDGE. REFFERENCE MDRS 1213643-2008-00258 & 1213643-2008-00259 FOR INFORMATION 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". REPORTED THAT PT'S WIFE TREATS WOUNDS DAILY AND CONTINUES TO CUT AND REMOVE MESH FROM HIS OPEN WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MESH FTL FTL DAVOL, INC., SUB. C.R. BARD, INC. NA 43END207

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R