BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SOFT MESH

    MDR report key: 3802832 · Received May 5, 2014

    Report

    Report Number
    1213643-2014-00127
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    December 18, 2009
    Report Date
    April 7, 2014
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033814
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK TO WHAT EXTENT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS ALLEGED A BARD SOFT MESH WAS IMPLANTED IN THE PT IN (B)(6) 2007. THE PRODUCT IDENTIFIERS FOR THE DEVICE ALLEGED TO HAVE BEEN IMPLANTED WAS FOR A DEVICE MANUFACTURED IN 2010 AND AS SUCH COULD NOT HAVE BEEN IMPLANTED IN THE PT IN 2007. A MANUFACTURING REVIEW WAS PERFORMED ON THE LOT NUMBER SUPPLIED TO DAVOL AND FOUND NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE ALLEGED EVENT. IF ADDITIONAL EVENT AND/OR EVALUATION INFO IS OBTAINED, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING IS BASED OFF A REVIEW OF THE PT'S MEDICAL RECORDS AND PT'S LEGAL FACT SHEET PROVIDED TO DAVOL BY THE PT'S ATTORNEY: ON (B)(6) 2012 - THE PT UNDERWENT A PELVIC REPAIR PROCEDURE WITH IMPLANTATION OF A BARD SOFT MESH. APPROXIMATELY ONE MONTH LATER THE PT PRESENTED FOR A FOLLOW UP VISIT IN WHICH THE PT STATES THAT SHE HAS IMPROVED BLADDER CONTROL. IT IS NOTED IN THE MEDICAL RECORD THAT THE PT WAS NON-COMPLAINT AND HAD RESUMED SEXUAL ACTIVITY TWO WEEKS POST OPERATIVELY, AND HER HUSBAND CAN FEEL SOMETHING "SHARP". ON (B)(6) 2008 - THE PT UNDERWENT A PROCEDURE WHERE SOME EXPOSED MESH WAS TRIMMED DUE TO COMPLAINTS OF URGENCY SYMPTOMS. ON (B)(6) 2008 - THE PT UNDERWENT ANOTHER PROCEDURE WHERE A FEW STRANDS OF MESH IN THE MIDLINE WERE TRIMMED DUE TO COMPLAINS OF DYSPAREUNIA. ON (B)(6) 2008 - THE PT HAD A FOLLOW UP WHERE SHE COMPLAINED OF DYSPAREUNIA. THE PT UNDERWENT A PROCEDURE WHERE FIBERS AGAIN WERE VISIBLE. THE PT WAS INJECTED WITH LIDOCAINE BELOW THE MESH AFTER WHICH A METZENBAUM SCISSOR WAS USED TO DISSECT MUCOSA DOWN BELOW THAT MENTION RESECTION OF A SMALL BAND. THE MUCOSA WAS THEN RE-APPROXIMATED ANTERIOR TO POSTERIOR WITH CHROMIC SUTURES. ON (B)(6) 2009 - IT IS ALLEGED IN THE PT'S LEGAL FACT SHEET THAT THE PT UNDERWENT MESH REMOVAL DUE TO COMPLIANT OF PAIN AND DISCOMFORT. THERE WERE NO OPERATIVE NOTES OR PRODUCT IDENTIFIERS PROVIDED FOR THIS PROCEDURE. ON (B)(6) 2010 - THE PT UNDERWENT IMPLANT OF NON-BARD DEVICE. THERE WAS NO MENTION OF THE BARD SOFT MESH DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266150 BARD SOFT MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUUGO542

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention| S