BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOLEY CATHETER, 16 FR

    MDR report key: 31739 · Received April 4, 1996

    Report

    Report Number
    MW1008809
    Event Type
    Other
    Date Received
    April 4, 1996
    Date of Event
    March 19, 1996
    Report Date
    March 27, 1996
    Manufacturer
    C.R. BARD, INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT IN OR FOR D&C FOLLOWED BY VAGINAL HYSTERECTOMY, RIGHT SALPINGO-OOPHORECTOMY, CULDOPLASTY, CYSTOURETHROCELE AND RECTOCELE REPAIR AND PERINEORRAPHY. DURING FINAL STAGE AN ATTEMPT WAS MADE TO PUT A FOLEY CATHETER INTO THE BLADDER. 300CC OF METHYLENE BLUE-TINGED WATER WAS PUT IN AND AN ATTEMPT WAS MADE TO INSERT THE SUPRAPUBIC CATHETER INTO THE BLADDER. HOWEVER, THE METHYLENE BLUE COULD NOT BE DRAINED OUT. A CYSTOSCOPY DISCLOSED A FALSE SPACE CREATED IN THE URETHRA. THE CATHETER WAS REMOVED AND REINSERTED WITHOUT SERIOUS ADVERSE IMPACT ON THE PT. UROLOGIST CONSULTED; CYSTOSCOPY PERFORMED; NEW SUPRAPUBIC CATHETER INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOLEY CATHETER, 16 FR FOLEY CATHETER KOD C.R. BARD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other