BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPILONG SOFT

    MDR report key: 1951138 · Received December 22, 2010

    Report

    Report Number
    9611612-2010-00024
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 22, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT, NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFO BECOMES AVAILABLE AND IN CASE NO CORRECTIVE/PREVENTIVE ACTION IS INDICATED, PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6). USER'S NARRATIVE: CLAMPING ADAPTER GOT LOOSENED WHEN OPENED AGAIN AFTER SEVERAL HOURS IN PLACE. INVESTIGATION STILL RUNNING. SIX SAMPLES SENT IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPILONG SOFT 868.5140 ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0431157-51 881

    Patients

    Seq Age Sex Outcome Treatment
    1 Other