BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3232252 · Received July 8, 2013

    Report

    Report Number
    1213643-2013-00289
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    July 27, 2004
    Report Date
    June 8, 2017
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 PT'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 ADD'L INFO. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT, ADDITIONALLY, NO PRODUCT WAS RETURNED FOR EVAL. THE MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L EVENT AND/OR EVAL INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO DAVOL BY THE PT'S ATTORNEY. ON (B)(6) 2003, PT WAS IMPLANTED WITH A BARD FLAT MESH DURING A VAGINAL PROCEDURE, ALSO UTILIZING ANOTHER COMPANY'S PRODUCTS. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ADD'L MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310212 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43FND090

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention| S