BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENUS SUPRA

    MDR report key: 3368371 · Received September 17, 2013

    Report

    Report Number
    3005665377-2013-00001
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Manufacturer
    HERAEUS KULZER GMBH
    Product Code
    EHJ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (THE IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HERAEUS (B)(4) (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.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467979 VENUS SUPRA EHJ-ABRASIVE DISK EHJ HERAEUS KULZER GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1