BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX MESH

    MDR report key: 1053311 · Received May 23, 2008

    Report

    Report Number
    1213643-2008-00312
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    May 22, 2006
    Report Date
    April 23, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    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 EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT REPORTS OF SURGERY TO EXPLANT A MARLEX MESH DUE TO INFECTION AFTER APPROX. EIGHT YEARS OF INDWELLING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention MESH WAS EXPLANTED AND REPAIRED WITH ANOTHER MESH.