BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 1810586 · Received August 4, 2010

    Report

    Report Number
    1213643-2010-00370
    Event Type
    Injury
    Date Received
    August 4, 2010
    Report Date
    July 14, 2010
    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 Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED NOR HAS A SPECIFIC PRODUCT PROBLEM BEEN REPORTED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. VOLUNTARY (B)(4) WAS RECEIVED AFTER INITIAL COMPLAINT WAS REPORTED. NO ADDITIONAL INFO WAS RECEIVED IN THE VOLUNTARY REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED: (B)(6)2008 - PT UNDERWENT OPEN BILATERAL INGUINAL HERNIA REPAIR PROCEDURES. PT REPORTED HE HAS BEEN EXPERIENCING PAIN BILATERALLY SINCE THE TIME OF IMPLANT, LEFT SIDE MORE PAINFUL THAN RIGHT. UNK DATES - PT HAS UNDERGONE NERVE BLOCK PAIN MANAGEMENT THERAPY ON THE LEFT SIDE. ON (B)(6)2010 - PT HAD AN MRI OF THE MESH IMPLANT AREAS, THE PT IS NOT AWARE OF THE RESULTS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSI2021

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other