BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3231595 · Received July 12, 2013

    Report

    Report Number
    1213643-2013-00305
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    July 1, 2013
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT'S ATTORNEY DID NOT ALLEGE A SPECIFIC DEVICE FAILURE AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE, HOWEVER, CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND IF AVAILABLE, TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. 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 PATIENT'S ATTORNEY: (B)(6) 2005 - THE PATIENT WAS IMPLANTED WITH A BARD FLAT MESH DURING A VAGINAL WALL REPAIR PROCEDURE. 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
    323041 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43KOD436

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability