BEUDAMED
    FDA Adverse Event Other Summary report: N

    PE ADULT-PED WET W/ATS LF

    MDR report key: 482469 · Received September 8, 2003

    Report

    Report Number
    1221601-2003-00010
    Event Type
    Other
    Date Received
    September 8, 2003
    Date of Event
    August 11, 2003
    Report Date
    September 8, 2003
    Manufacturer
    GENZYME BIOSURGERY A DIVISION OF GEN
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT "SOMETHING HAPPENED TO THE SUCTION CONTROL PORTION AND THE BLUE WATER FROM THE WATERSEAL SPLASHED OUT OF THE SUCTION CONTROL AND ONTO THE NURSE, "ALLEGEDLY BURING THEIR HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PE ADULT-PED WET W/ATS LF CHEST DRAINAGE DEVICE CAC GENZYME BIOSURGERY A DIVISION OF GEN A-7000LF 574135

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other