BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2082107 · Received April 21, 2011

    Report

    Report Number
    2082107
    Date Received
    April 21, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ETHICON
    Product Code
    HET
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    MORECELLATOR FAILED TO MORECELLATE FIBROID UTERUS. DEVICE CHANGED AND CASE CONTINUED WITHOUT INCIDENT. EQUIPMENT SENT OUT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * GYNCARE/MORECELLEX TISSUE MORCELLATOR HET ETHICON MX0100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR