BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATEX FOLEY CATHETER

    MDR report key: 4320497 · Received November 29, 2014

    Report

    Report Number
    1417592-2014-00111
    Event Type
    Injury
    Date Received
    November 29, 2014
    Date of Event
    October 31, 2014
    Report Date
    November 25, 2014
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    NWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING AN OUTPATIENT BACK SURGERY, WHEN ATTEMPTING TO REMOVE THE CATHETER, THE BALLOON WOULD NOT DEFLATE. THE STAFF TRIED TO DEFLATE THE BALLOON WITH A SYRINGE AND ALSO CUT THE CATHETER, BUT THE BALLOON WOULD NOT PASSIVELY DEFLATE. A UROLOGIST CAME AND RUPTURED THE BALLOON USING A GUIDE WIRE. THE CATHETER WAS REMOVED WITHOUT FURTHER INCIDENT. THE SAMPLE WAS NOT RETURNED FOR EVAL. WE HAVE NO LOT NUMBER. A ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE BALLOON WOULD NOT DEFLATE AND WAS MANUALLY RUPTURED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773142 LATEX FOLEY CATHETER NWR MEDLINE INDUSTRIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention