BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4071229 · Received September 2, 2014

    Report

    Report Number
    1213643-2014-00311
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 5, 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
    NY, US
    Reporter Occupation
    OTHER

    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 VALID 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) 2001 - THE PT HAD A BARD/DAVOL FLAT MESH IMPLANTED DURING AN UNK PELVIC PROCEDURE. THE ATTORNEY'S REPORT ALLEGES PAIN, INJURY, "PAIN AND SUFFERING" DISABILITY, AND DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532453 BARD FLAT MESH FTL DAVOL INC, SUB C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability