BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 4071226 · Received September 2, 2014

    Report

    Report Number
    1213643-2014-00309
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    July 20, 2017
    Manufacturer
    DAVOL INC, SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NOT EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. 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 PT'S ATTORNEY: ON (B)(6) 2010 - THE PT WAS IMPLANTED WITH A NO-DAVOL TVT-S DEVICE. ON (B)(6) 2011 - THE PT WAS IMPLANTED WITH A BARD/DAVOL FLAT MESH. THE ATTORNEY'S REPORT ALLEGES PAIN, INJURY, AND DISABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532452 BARD FLAT MESH FTL DAVOL INC, SUB. C.R. BARD, INC. NA HUUG2215

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability