BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 2963322 · Received December 28, 2012

    Report

    Report Number
    1213643-2012-00905
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    February 5, 2012
    Report Date
    December 4, 2012
    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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A SPECIFIC DEVICE FAILURE WAS NOT ALLEGED AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WITHOUT A LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, IT APPEARS AS THOUGH THE MESH REMAINS IMPLANTED. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED VIA (B)(4) REPORT (B)(4) AND BY THE PATIENT: (B)(6) 2012-- PATIENT WAS IMPLANTED WITH BARD MESH FOR UMBILICAL HERNIA REPAIR. SINCE IMPLANT PATIENT HAS HAD PAIN THAT LIMITS MOBILITY. PATIENT IS IN CONSTANT PAIN, AND TAKES PAIN MEDICATION ON A DAILY BASIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability