BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOLEY CATHETER

    MDR report key: 6030477 · Received October 14, 2016

    Report

    Report Number
    1417592-2016-00110
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 17, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    EZL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A MALE PATIENT PRESENTED IN THE EMERGENCY ROOM ON (B)(6) 2016, WAS DIAGNOSED WITH A URINARY TRACT INFECTION AND WAS ADMITTED TO THE HOSPITAL. THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2016 AND REMAINED IN PLACE UNTIL (B)(6) 2016 WHEN IT FELL OUT. THE NURSE STATED THERE WAS A TEAR IN THE BALLOON. NO OTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT'S CONDITION OR COMORBIDITIES. A NEW CATHETER WAS THEN INSERTED. THERE WAS NO PATIENT INJURY OR NEED FOR ADDITIONAL INTERVENTION. THE NURSE STATED THESE CATHETERS ARE USED THROUGHOUT THEIR FACILITY WITHOUT SIMILAR ISSUES. THE CATHETER WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE HAS NOT BEEN DETERMINED. DUE TO THE REPORTED NEED FOR A NEW CATHETER TO BE INSERTED, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE FOLEY CATHETER FELL OUT ALLEGEDLY DUE TO A RUPTURED BALLOON AND WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682280 FOLEY CATHETER EZL MEDLINE INDUSTRIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other