BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ELASTOMER COATED FOLEY

    MDR report key: 59897 · Received December 23, 1996

    Report

    Report Number
    9610849-1996-90001
    Event Type
    Injury
    Date Received
    December 23, 1996
    Date of Event
    October 1, 1996
    Report Date
    November 26, 1996
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    FCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED CATHETER WOULD NOT DEFLATE. CUT CATHETER, STILL COULD NOT REMOVE. WENT TO A UROLOGIST WHO COULD NOT REMOVE CATHETER. DR. SENT HIM TO HOSP. BALLOON WAS POPPED IN HOSP BY INSERTING NEEDLE THROUGH ABDOMEN. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ELASTOMER COATED FOLEY FOLEY CATHETER FCN SHERWOOD DAVIS AND GECK NA 876374

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization