BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 100% SILICONE 2 WAY 5CC 18FR

    MDR report key: 3070316 · Received April 17, 2013

    Report

    Report Number
    8040412-2013-00073
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 25, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE DEVICE IS AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: IT WAS REPORTED IN THE RECOVERY ROOM, THE CATHETER WAS FOUND IN THE PT'S BED WITH THE BALLOON DEFLATED. THE CATHETER WAS INSERTED SEVERAL HOURS BEFORE FOR A RADICAL PROSTATECTOMY. THE BALLOON WAS PRETESTED AND WAS FINE AND HADE BEEN CHECKED DURING THE SURGERY. THE CATHETER WAS REPLACED WITHOUT INCIDENT. NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166304 RUSCH 100% SILICONE 2 WAY 5CC 18FR FOLEY CATHETER EZL TELEFLEX MEDICAL 12JE44

    Patients

    Seq Age Sex Outcome Treatment
    1