BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG SONO

    MDR report key: 1725675 · Received June 1, 2010

    Report

    Report Number
    9611612-2010-00008
    Event Type
    Other
    Date Received
    June 1, 2010
    Report Date
    June 1, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K013041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER EXPERIENCE REPORT HAS NOT YET BEEN SENT IN TO MFR BY USER FACILITY. THE DEVICE HAS NOT BEEN RETURNED TO MFR FOR EVAL. AT THIS POINT NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. ADD'L INFO WILL BE PROVIDED IN A F/U REPORT IF FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    (B)(4). REPORTED ORALLY, CUSTOMER EXPERIENCE REPORT REQUESTED. INNER COIL OF THE CATHETER IS REPORTED TO BE REMOVED/DRAWN OUT AND STRETCHED UPON REMOVAL OF THE CATHETER. PT IS DOING WELL. CURRENTLY NO FURTHER INFO / NO PRODUCT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXOLONG SONO ANAESTHESIA CONDUCTING KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531157-31A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other