BEUDAMED
    FDA Adverse Event Other Summary report: N

    NI

    MDR report key: 375721 · Received December 3, 2001

    Report

    Report Number
    MW4003189
    Event Type
    Other
    Date Received
    December 3, 2001
    Report Date
    December 3, 2001
    Manufacturer
    *
    Product Code
    CBF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT REPORTEDLY HAD FILED IN COURT A COMPLAINT AGAINST OPERATOR/PRODUCT AT 8-10 YEARS AGO. CURRENT COMPLAINT CONTINUES THAT THESE HYPERBARIC OXYGEN CHAMBERS ARE DANGEROUS AND CAN CAUSE INJURY. THEY BELIEVE THAT THE UNITS IN USE ARE THE SAME UNITS THAT WERE IN OPERATION WHEN THEY SUFFERED THE OXYGEN TOXICITY PROBLEM. LOST LAWSUIT. COMPLAINANT INDICATES THAT THEY GOT OXYGEN TOXICITY WHEN THEY WERE A TECHNICIAN OPERATING THE HYPERBARIC CHAMBERS, YET THEY WERE NOT IN THE UNIT DURING HYPERBARIC CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54410 NI HYPERBARIC OXYGEN CHAMBER CBF * NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other