BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3252272 · Received July 22, 2013

    Report

    Report Number
    1213643-2013-00313
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 1, 2013
    Manufacturer
    DAVOL INC, SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 OR PT INJURY. WITHOUT A LOT NUMBER A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVALUATION. WITH THE CURRENT AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE AT THIS TIME. IF ADDITIONAL EVENT AND/OR EVALUATION INFORMATION IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF THE PT'S MEDICAL RECORDS WHICH WERE PROVIDED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 1994 - THE PT WAS IMPLANTED WITH AN UNK BARD FLAT MESH DURING A VAGINAL VAULT PROLAPSE REPAIR. IT WAS ALSO REPORTED THAT THE PT WAS IMPLANTED WITH TWO NON-BARD MESH DEVICES FOR AN UNK PROCEDURE IN 2008 AND 2009. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADDITIONAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339819 BARD FLAT MESH FTL DAVOL INC, SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability