BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXITIME

    MDR report key: 6635225 · Received June 12, 2017

    Report

    Report Number
    3011203516-2017-00003
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 24, 2017
    Manufacturer
    HERAEUS KULZER SRL
    Product Code
    ELW
    PMA / PMN Number
    K091494
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    AS ALLOWED BY EXEMPTION #E2015010, HERAEUS KULZER LLC (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS KULZER SRL (THE MANUFACTURER). ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. NARRATIVE FOR SECTION H6 METHOD, RESULTS AND CONCLUSIONS CODES THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. H3 OTHER TEXT: NOT RESPONSIVE TO INQUIRIES, NO RETURN.

    Description of Event or Problem · 0

    PATIENT SWALLOWED SOME FLEXITIME CORRECT FLOW IMPRESSION MATERIAL 20 MINUTES BEFORE CALL TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415267 FLEXITIME MATERIAL, IMPRESSION ELW HERAEUS KULZER SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention