BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD FLAT MESH

    MDR report key: 3952029 · Received July 16, 2014

    Report

    Report Number
    1213643-2014-00232
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 24, 2010
    Report Date
    June 18, 2014
    Manufacturer
    DAVOL INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, WE ARE UNABLE TO DETERMINE TO WHAT EXTENT, IF ANY, THE BARD DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENTS AS REPORTED. ADD'L INFO HAS BEEN REQUESTED. A MANUFACTURING REVIEW WAS PERFORMED AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THIS MDR INCLUDES ALL PT, EVENT AND DEVICE INFO DAVOL HAS RECEIVED TO DATE. IF ADD'L INFO IS OBTAINED, A F/U MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    TH FOLLOWING IS BASED ON MEDICAL RECORDS PROVIDED BY THE PT'S ATTORNEY: ON (B)(6) 2009, THE PT WAS IMPLANTED WITH MULTIPLE PELVIC DEVICES INCLUDING A BARD/DAVOL FLAT MESH, DURING AN ABDOMINAL SACROCOLPOPEXY AND TRANSVAGINAL TAPING PROCEDURE. ON (B)(6) 2010, THE PT UNDERWENT RECURRENT RECTOCELE REPAIR WITH A NON BARD/DAVOL DEVICE. THERE WAS NO VISUALIZATION OF THE FLAT MESH DURING THIS PROCEDURE. ON (B)(6) 2011, PHYSICIAN NOTES: RECURRENT UTI'S STATUS POST SACROCOLPOPEXY, SLING AND RECTOCELE REPAIR. THE PT COMPLAINS OF DYSURIA WHICH RETURNS AFTER STOPPING ANTIBIOTICS, SOME BULGING IN THE VAGINAL AREA AND CHRONIC CONSTIPATION. THE PT HAS A TINY BIT OF LEAKAGE WITH COUGHING AND SNEEZING BUT STATES THIS DRAMATICALLY IMPROVED. ON (B)(6) 2012, PHYSICIAN PROGRESS NOTES: PAIN INTERMITTENT WHEN GOING FROM STANDING TO SITTING AND OCCASIONALLY THIS WILL BE RELIEVED WITH URINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415900 BARD FLAT MESH FTL DAVOL INC. NA HUTA1322

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Disability