BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUTTNAUER AUTOCLAVE

    MDR report key: 34998 · Received June 3, 1996

    Report

    Report Number
    2435367-1996-00002
    Event Type
    Other
    Date Received
    June 3, 1996
    Date of Event
    February 16, 1996
    Report Date
    May 30, 1996
    Manufacturer
    TUTTNAUER CO LTD.
    Product Code
    FLE
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AUTOCLAVE, HAS CAUSED INJURIES TO A PT OF AN EYE CENTER. UPON INVESTIGATION, DISTRIBUTOR FOUND THAT OVER TIGHTENING OF DOOR LOCKING DEVICE CAUSED THE DOOR TO POP OPEN APPROX. 1/8" AND ALLOW STEAM TO ESCAPE THROUGH THIS SPACE. IN THIS CASE, THE SAFETY LATCH FUNCTIONED PROPERLY, AS DESIGNED, PREVENTING THE DOOR FROM OPENING ANY FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUTTNAUER AUTOCLAVE STERILIZER FLE TUTTNAUER CO LTD. 2540MK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other