BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLING PROCEDURE

    MDR report key: 289100 · Received August 5, 2000

    Report

    Report Number
    MW1019527
    Event Type
    Injury
    Date Received
    August 5, 2000
    Date of Event
    April 11, 1998
    Report Date
    August 5, 2000
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FHK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT WAS SCHEDULED TO HAVE A HYSTERECTOMY DUE TO PROLAPSE OF UTERUS WHICH WAS CAUSING LEAKAGE, FROM HAVING 5 CHILDREN, PUTTING PRESSURE ON BLADDER FROM UTERUS. GYNECOLOGIST SUGGESTED PT HAVE SLING PROCEDURE DONE BY ASSOCIATE DR. PT ASKED IF THERE WAS A POSSIBILITY THAT JUST HAVING THE UTERUS REMOVED WOULD RELIEVE PRESSURE FROM BLADDER AND CORRECT PROBLEM. PT WAS TOLD THAT IF THEY HAD THIS PROCEDURE, INSURANCE WOULD BE MORE APT TO APPROVE IT BECAUSE IT WAS A TRIAL AND THEY WOULD GET 3000.00 OFF THE COST. NOW PT FINDS OUT THAT THE SYNTHETIC MATERIAL USED HAS BEEN RECALLED AND IS ERODING IN WOMEN. PT HAS HAD CONSTANT PAIN SINCE SURGERY AND WAS TOLD NOTHING WAS WRONG. PT LIVES WITH CONSTANT PAIN. CAN'T TAKE A BATH BECAUSE VAGINAL WALL GETS CRAMPING PAIN, UNUSUAL PAIN. PT IS LEAKING AGAIN AND KIDNEYS HURT AND LOWER BACK ALL THE TIME. PT HAS BEEN GOING TO PRIMARY DR WHO SAYS BLOOD IS IN URINE EVERY TIME THEY CHECK AND PT VISITED AN ASSOCIATE OF DR WHO WANTS TO CONSULT TO SEE WHAT TO DO. PT WANTS THIS MATERIAL TAKEN OUT. PT DOESN'T KNOW WHAT TO DO NOW AND CAN'T LIVE WITH THIS PAIN ANY LONGER AND BEING TOLD NOTHING IS WRONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLING PROCEDURE SCREWS SYNTHETIC MATERIAL SEWED INTO VAGINAL WALL. FHK BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other| R| S