BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCHR ASSEMBLY

    MDR report key: 837046 · Received October 17, 2006

    Report

    Report Number
    1222895-2006-00004
    Event Type
    Malfunction
    Date Received
    October 17, 2006
    Report Date
    September 19, 2006
    Manufacturer
    INTEGRA RADIONICS, INC.
    Product Code
    HAW
    PMA / PMN Number
    k923522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER MADE VAGUE REFERENCE TO THIS INCIDENT IN CORRESPONDENCE REPORTING MDR 1222895-2006-00003 TO THE MANUFACTURING FACILITY. DETAILS REGARDING THE INCIDENT INCLUDING DATE OF INCIDENT, AVAILABILITY OF THE DEVICE FOR EVALUATION, AND PATIENT INFORMATION HAVE NOT YET BEEN RECEIVED FROM THE USER FACILITY. ATTEMPTS HAVE BEEN MADE TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION FROM THE USER FACILITY IS MADE AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE USER FACILITY WAS TREATING A PATIENT WHILE USING THE UCHRA. THEY STATED THAT NEAR THE END OF THE PROCEDURE, THE SCREW ON THE HEAD RING POST BROKE. IT WAS REPORTED BY THE USER FACILITY THAT NO PATIENT INJURY OCCURRED AND THE INCIDENT OCCURRED SEVERAL MONTHS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UCHR ASSEMBLY HAW HAW INTEGRA RADIONICS, INC. UCHRA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other