BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 3170112 · Received June 5, 2013

    Report

    Report Number
    1213643-2013-00246
    Event Type
    Injury
    Date Received
    June 5, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033814
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 OPERATIVE REPORTED PROVIDED WITH THE INITIAL ATTORNEY'S REPORT INDICATED THAT THE PT WAS IMPLANTED WITH A BARD SOFT MESH FOR REPAIR OF STRESS URINARY INCONTINENCE. NO SPECIFIC DEVICE HAS BEEN ALLEGED AND THE MEDICAL RECORDS PROVIDED INCLUDED ONLY THE OPERATIVE REPORT FOR THE IMPLANT PROCEDURE. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFO. ADDITIONALLY, NO SAMPLE HAS BEEN RETURNED. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADDITIONAL EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON MEDICAL RECORDS (OPERATIVE REPORT) PROVIDED BY THE PT'S ATTORNEY: (B)(6) 2008 - PT UNDERWENT A PUBO-VAGINAL MID-URETHRAL SLING SUSPENSION FOR REPAIR OF STRESS URINARY INCONTINENCE AND WAS IMPLANTED WITH A BARD SOFT MESH. THE SLING WAS CONSTRUCTED OUT OF THE BARD SOFT MESH. THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY: IT IS ALLEGED ON (B)(6) 2008, THE PT WAS IMPLANTED WITH A PROLENE MESH. 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
    249714 BARD SOFT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA DAQL0015

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability