BEUDAMED
    FDA Adverse Event Other Summary report: N

    STIMULONG NANOLINE

    MDR report key: 1719455 · Received May 4, 2010

    Report

    Report Number
    9611612-2010-00006
    Event Type
    Other
    Date Received
    May 4, 2010
    Date of Event
    April 13, 2010
    Report Date
    May 3, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K043130
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO MANUFACTURER FOR EVAL. INVESTIGATION STILL IS NOT COMPLETED. THE REPORT WILL BE SUMMARIZED AND SENT IN TO FDA AS SOON AS IT IS AVAILABLE. 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. THE INCIDENT SEEMS TO BE CAUSED BE THE PT. INVESTIGATIONS WILL FOCUS ON FRAGMENTS REMAINING WITH THE PT. ADD'L INFO WILL BE PROVIDED IN A FOLLOW UP REPORT IF FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    EVENT TOOK PLACE IN (B)(6). PROFESSIONAL USERS NARRATIVE TENTATIVE TRANSLATION ((B)(4) TO ENGLISH): THREE DAYS POST KNEE-INTERVENTION (TEP), THE CATHETER WAS INTENDED TO BE REMOVED FROM THE PT. PHYSICIAN FOUND CATHETER IN BED, PATIENT CONFUSED, PROBABLY PULLED CATHETER OUT OF INSERTION SITE. X-RAY VISUALISATION DID NOT SHOW ANY FOREIGN BODIES IN PT, PT WAS SENT HOME AND SHOULD BE OBSERVED BY FAMILY DOCTOR. PT IS DOING WELL. CATHETER WAS SENT IN TO MANUFACTURER FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STIMULONG NANOLINE 868.5140 ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531156-32B 838

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other