BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 1222124 · Received November 5, 2008

    Report

    Report Number
    2210968-2008-01069
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/05/2008. URINARY RETENTION OCCURRED - CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE IN 2008. FOLLOWING THE PROCEDURE, THE PATIENT HAD TO USE A CATHETER EVERY FOUR HOURS. THE PATIENT SOMETIMES HAD THE URGE TO URINATE AND WAS ABLE TO INDEPENDENTLY VOID 25 TO 100 ML'S. THE PATIENT WENT TO THE EMERGENCY ROOM FOUR DAYS LATER, AFTER FEELING SICK TO HER STOMACH FOR ONE WEEK AND A URINE SPECIMEN WAS TAKEN. TWO DAYS LATER, THE PATIENT STARTED SELF-CATHETERIZING. AT THE OFFICE APPOINTMENT WITH THE SURGEON FOUR DAYS LATER, THE CATHETER WAS RE-INSERTED. AT THE OFFICE APPOINTMENT SIX DAYS LATER, THE CATHETER WAS REMOVED AND THE PATIENT STARTED SELF-CATHETERIZING AGAIN. FOUR DAYS LATER, THE PATIENT WAS TOLD BY THE DOCTOR'S OFFICE THAT A POSITIVE URINARY TRACT INFECTION WAS NOTED ON THE SPECIMEN TAKEN FOUR DAYS PRIOR, AND THE PATIENT WAS PUT ON NITRODUR. THE FOLLOWING MONTH, THE PATIENT SAW THE SURGEON AND A SECOND SURGERY IS SCHEDULED FOR 2008, TO REMOVE THE TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention