BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPLEX® NANOLINE®

    MDR report key: 22436772 · Received July 8, 2025

    Report

    Report Number
    9611612-2025-00028
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    November 23, 2023
    Report Date
    July 8, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    UDI-DI
    04048223043486
    PMA / PMN Number
    K053283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS REPORTED IN RETROSPECT BASED ON A RE-EVALUATION CONDUCTED IN 2025 FOR FORMAL REASONS. THERE WAS NO PARTICULAR RISK TO PATIENTS, USERS, OR THIRD PARTIES.

    Description of Event or Problem · 0

    (B)(4). INCIDENT OCCURRED IN BRAZIL: THE MATERIAL USED BROKE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387588 UNIPLEX® NANOLINE® UNIPLEX® NANOLINE® BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 1471 04048223043486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention