BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTFE MESH

    MDR report key: 6146088 · Received December 5, 2016

    Report

    Report Number
    1213643-2016-00555
    Event Type
    Injury
    Date Received
    December 5, 2016
    Report Date
    December 5, 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. MEDICAL RECORDS WERE LIMITED TO THE IMPLANT TRACKING LOG AND IMPLANT OPERATIVE REPORT ONLY. IT IS ALLEGED THE PATIENT EXPERIENCED PAIN, INFECTION AND INCONTINENCE. IN REGARDS TO INFECTION, THE WARNING SECTION OF THE INSTRUCTIONS-FOR-USE STATES "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. THE PROSTHESIS MAY NOT HAVE TO BE REMOVED. AN UNRESOLVED INFECTION, HOWEVER, MAY REQUIRE REMOVAL OF THE PROSTHESIS.¿ 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. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    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) 2006 - THE PATIENT WAS DIAGNOSED WITH POST HYSTERECTOMY VAGINAL VAULT PROLAPSE AND MIXED URINARY INCONTINENCE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A DAVOL PTFE MESH, A COMBINED ANTERIOR/POSTERIOR REPAIR, IMPLANT OF A NON DAVOL "URETEX" MESH PUBOVAGINAL SLING AND CYSTOSCOPY WITH A SUPRAPUBIC CATHETER PLACEMENT. IT IS ALLEGED THAT AT SOME POINT POST PROCEDURE THE PATIENT EXPERIENCED INFECTIONS, INCONTINENCE AND PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796670 PTFE MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. 43GPD203

    Patients

    Seq Age Sex Outcome Treatment
    1 Other