BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 8FR 100% SILICONE FOLEY 2-WAY

    MDR report key: 3061261 · Received April 10, 2013

    Report

    Report Number
    8040412-2013-00064
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 19, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RECEIVED BY MANUFACTURER IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: A PEDIATRIC HOME CARE PT WAS HAVING HIS CATHETER REMOVED BUT THE BALLOON WOULD NOT DEFLATE, SO IT COULD NOT BE REMOVED. INTERVENTION: THE PT HAD TO HAVE THE CATHETER REMOVED UNDER ANESTHESIA. PT'S CURRENT CONDITION IS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148239 RUSCH 8FR 100% SILICONE FOLEY 2-WAY FOLEY CATHETER KOD TELEFLEX MEDICAL 121E37

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention