BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3231874 · Received July 10, 2013

    Report

    Report Number
    1213643-2013-00293
    Event Type
    Injury
    Date Received
    July 10, 2013
    Report Date
    June 25, 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
    MO, 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. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVAL 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) 2008 - THE PT WAS IMPLANTED WITH A BARD FLAT MESH DURING A CYSTOSCOPY WITH A BILATERAL URETERAL STENT PLACEMENT PROCEDURE. (B)(6) 2009 - THE PT WAS IMPLANTED WITH A NON-BARD DEVICE FOR AN UNSPECIFIED REPAIR. 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
    318540 BARD FLAT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43AOD104

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability