BEUDAMED
    FDA Adverse Event Other Summary report: N

    AQUA SEAL CHEST DRAINAGE UNITS

    MDR report key: 185293 · Received September 2, 1998

    Report

    Report Number
    9611018-1998-00014
    Event Type
    Other
    Date Received
    September 2, 1998
    Report Date
    August 14, 1998
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    KDQ
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS FLOW CONTROL VALVES ON AQUA SEAL UNITS DID NOT WORK. CONTINUOUS BUBBLING WAS SEEN IN THE SUCTION CONTROL CHAMBER. NO PT INJURY IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA SEAL CHEST DRAINAGE UNITS CHEST DRAINAGE UNIT KDQ SHERWOOD MEDICAL INDUSTRIES NA 98A106T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN WALL SUCTION.