BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 129594 · Received September 30, 1997

    Report

    Report Number
    MW4002034
    Date Received
    September 30, 1997
    Report Date
    September 30, 1997
    Manufacturer
    LEISEGANG MEDICAL, INC
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RPTR STATED THAT THE MFR IS AWARE OF, AND NOT REPORTING SEVERAL EVENTS WHERE THE PT WAS SIGNIFICANTLY BURNED DUE TO A KNOWN DESIGN PROBLEM WITH THE OFFICE MODEL ESU UNITS. RPTR STATED THAT CORPORATE MGR. HAD A "VINDICTIVE NATURE" AND THEREFORE RPTR WAS CALLING FDA ANONYMOUSLY. RPTR ALSO STATES THEY THOUGHT THERE WAS A GROUP OF DOCTORS SUING THE CO. DUE TO THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ESU GEI LEISEGANG MEDICAL, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN