BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULONG SONO II NANOLINE®

    MDR report key: 20734153 · Received November 20, 2024

    Report

    Report Number
    9611612-2024-00028
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 21, 2024
    Report Date
    November 20, 2024
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    UDI-DI
    04048223117095
    PMA / PMN Number
    K113188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) COMPLAINT TOOK PLACE IN GERMANY. TWO LOT NUMBERS HAD COMPLAINTS (ASSIGNMENT UNDER 2.3F, 2.3I, 2.3J): LOT: 1517 MANUFACTURING DATE: 2023-12-06/ EXPIRY DATE: 2028-1 2-05. LOT: 1544 MANUFACTURING DATE: 2024-06-19/ EXPIRY DATE: 2029-06-18. THIS INITIAL REPORT SUMMARISES ALL THE TEST RESULTS THAT WERE POSSIBLE AT THE TIME OF THE REVIEW. BASED ON CLINICAL ASSESSMENT AND RISK ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE. A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    (B)(4) COMPLAINT TOOK PLACE IN GERMANY. ORIGINAL TEXT GERMAN: DRAHT GAR NICHT VORSCHIEBBAR, HÄNGT IN DER KATHETERSCHNECKE FEST. DRAHT IST DIE VERBINDUNG ZUM STIMULIERBAREN KATHETER. TRANSLATION INTO ENGLISH: WIRE CANNOT BE ADVANCED AT ALL, IS STUCK IN THE CATHETER SCREW. THE WIRE IS THE CONNECTION TO THE STIMULABLE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422206 STIMULONG SONO II NANOLINE® STIMULONG SONO II NANOLINE®_ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 03115137EB 1517, (1544) 04048223117095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other