BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3854890 · Received May 23, 2014

    Report

    Report Number
    1213643-2014-00161
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    February 12, 2015
    Report Date
    December 12, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    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 OR PT INJURY AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED. WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADD'L INFO AND TO REQUEST RETURN OF THE DEVICE FOR EVAL. A MFG REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MFG RELATED CAUSE FOR THE ALLEGED EVENT. 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) 2011, THE PT UNDERWENT A SUPRACERVICAL HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND TRANSOBTURATOR TAPE PLACEMENT USING A BARD FLAT MESH DUE TO A DIAGNOSIS OF UTEROVAGINAL PROLAPSE. THE ATTORNEY'S REPORT ALLEGES PERMANENT INJURY, NERVE DAMAGE, PAIN AND SUFFERING, ABDOMINAL MEDICAL AND SURGICAL INTERVENTION, DEFECTIVE MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309119 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUJ1007

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S