BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4071227 · Received September 2, 2014

    Report

    Report Number
    1213643-2014-00313
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 6, 2014
    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
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WITHOUT A LOT NUMBER, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. 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 WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: (B)(6) 1995 - THE PT WAS IMPLANTED WITH A BARD/DAVOL "MARLEX" MESH DURING A HERNIA REPAIR SURGERY. ON (B)(6) 2015 - THE PT UNDERWENT UNSPECIFIED EMERGENCY SURGERY. THE ATTORNEY'S REPORT ALLEGES, PAIN, ADDITIONAL SURGICAL INTERVENTION, AND DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532324 BARD FLAT MESH FTL DAVOL INC, SUB C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S