BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE MESH

    MDR report key: 6171912 · Received December 13, 2016

    Report

    Report Number
    1213643-2016-00573
    Event Type
    Injury
    Date Received
    December 13, 2016
    Report Date
    December 13, 2016
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    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 OR PATIENT INJURY AND MEDICAL RECORDS WERE LIMITED TO THE PATIENT'S IMPLANT OP REPORT AND IMPLANT TRACKING LOG ONLY. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2007 - THE PATIENT WAS DIAGNOSED WITH A POST HYSTERECTOMY VAGINAL VAULT PROLAPSE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD PTFE MESH. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME ASSOCIATED TO THE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822468 PTFE MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43DQD132

    Patients

    Seq Age Sex Outcome Treatment
    1 Other