BEUDAMED
    FDA Adverse Event Summary report: N

    AUTOMATIC HIGH PRESSURE SURGICAL IRRIGATOR

    MDR report key: 26271 · Received September 29, 1995

    Report

    Report Number
    MW1007142
    Date Received
    September 29, 1995
    Date of Event
    September 5, 1995
    Report Date
    September 22, 1995
    Manufacturer
    ALTON DEAN MEDICAL, INC.
    Product Code
    FQH
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO HOSP'S O.R. PERSONNEL THE DEVICE BEGAN TO PRESSURIZE AS EXPECTED DURING A SURGICAL PROCEDURE. THE DEVICE, HOWEVER, "KEPT GOING" & THE SOLUTION BAG INSIDE UNIT BEGAN TO "BULGE OUT THE TOP". WHILE ATTEMPTING TO SHUT THE UNIT DOWN, THE DEVICE EXPLODED IN THE NURSE'S FACE RESULTING IN A SEVERE LACERATION TO HER UPPER LIP. THE DOOR LATCH WAS TORN FROM THE PLASTIC CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATIC HIGH PRESSURE SURGICAL IRRIGATOR SURGICAL IRRIGATOR FQH ALTON DEAN MEDICAL, INC. SI2000

    Patients

    Seq Age Sex Outcome Treatment
    1 *