BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOSURGERY UNIT

    MDR report key: 248804 · Received November 4, 1999

    Report

    Report Number
    MW1017474
    Event Type
    Malfunction
    Date Received
    November 4, 1999
    Date of Event
    September 23, 1999
    Report Date
    November 1, 1999
    Manufacturer
    WALLACH SURGICAL DEVICES, INC.
    Product Code
    GEH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM MFR 12/3/99: WITHOUT THE OPPORTUNITY TO EVALUATE THE UNIT IN QUESTION, CO CANNOT CONFIRM WHAT HAPPENED WITH THIS CRYOSURGICAL INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSURGERY UNIT WALLACH 2000 GEH WALLACH SURGICAL DEVICES, INC. WA4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other