BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 24827259 · Received April 9, 2026

    Report

    Report Number
    3014616394-2026-00015
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 9, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    04260182520703
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A4 IS UNKNOWN. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD.

    Description of Event or Problem · 0

    WE WERE INFORMED THAT THE DEVICE DEVELOPED A MUSHROOM SHAPE AFTER PLACEMENT AND WAS CONSEQUENTLY NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891868 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD21 2503292115 04260182520703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown