BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 8FR 100% SILICONE 3CC FOLEY

    MDR report key: 2961185 · Received January 28, 2013

    Report

    Report Number
    8040412-2013-00037
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 18, 2013
    Manufacturer
    INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS NOT BEEN RECEIVED BY MFR IN TIME FOR THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: ONE DAY AFTER INSERTION OF CATHETER SUPRAPUBICALLY AFTER SURGERY, THE FUNNEL HAD BROKEN OFF FROM THE SHAFT (NO FORCE APPLIED). THE CATHETER WAS REMOVED AND ANOTHER WAS INSERTED SUPRAPUBICALLY UNDER GENERAL ANESTHESIA. NO REPORTED PATIENT INJURY. PATIENT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36884 RUSCH 8FR 100% SILICONE 3CC FOLEY FOLEY CATHETER KOD INMED MFG.SDN.BHD,RUSCH., TELEFLEX MEDICAL 11AE05

    Patients

    Seq Age Sex Outcome Treatment
    1 13 MO Required Intervention