BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGYLE AQUA-SEAL

    MDR report key: 219239 · Received April 16, 1999

    Report

    Report Number
    9611018-1999-00002
    Event Type
    Death
    Date Received
    April 16, 1999
    Date of Event
    January 25, 1999
    Report Date
    March 18, 1999
    Manufacturer
    SHERWOOD MEDICAL INDUSTRIES
    Product Code
    CAC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE TRIALING THE DEVICE, A PT HAD A CHEST TUBE PULLED PERHAPS BEFORE AN AIR LEAK HAD BEEN RESOLVED WITH THE PT. FURTHER COMPLICATIONS RESULTED AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARGYLE AQUA-SEAL AUTO TRANSFUSION CHEST DRAINAGE UNIT CAC SHERWOOD MEDICAL INDUSTRIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death