BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM MEDICAL CORP

    MDR report key: 278315 · Received May 17, 2000

    Report

    Report Number
    1219977-2000-00002
    Event Type
    Injury
    Date Received
    May 17, 2000
    Date of Event
    March 9, 2000
    Report Date
    March 27, 2000
    Manufacturer
    ATRIUM MEDICAL CORP.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE TO RIGHT SIDE TO SUCTION DUE TO COMPLETE SPONTANEOUS RIGHT PNEUMOTHORAX. THE CHEST TUBE WAS PLACED TO WATER SEAL. CHEST X-RAY TAKEN 4 HOURS LATER AND TUBE PLACED BACK TO SUCTION. AT 0400 THE CHEST TUBE WAS PLACED TO WATER SEAL DUE TO MD ORDER. CHEST X-RAY WAS DONE AT 0800. AT 1155 MD NOTES NOT OBVIOUS AIR LEAK BUT LUNG DROPPED 20% ON WATER SEAL - BACK TO SUCTION. TO UNDERWATER SEAL. SMALL AIR LEAK NOTED. CHEST TUBE TO WATER SEAL. BACK TO SUCTION AFTER 1 HOUR. CHEST TUBE TO WATER SEAL. CHEST TUBE REMOVED AT 0925. NO AIR LEAK NOTED. 1040 30-40% PNEUMOTHORAX NOTED ON CHEST X-RAY. TO OPERATING ROOM AT 1130 FOR CHEST TUBE PLACEMENT. CHEST TUBE TO SUCTION. CHEST TUBE TO WATER SEAL. 50% PNEUMOTHORAX. CHEST TUBE BACK TO SUCTION. NO AIR LEAK NOTED. CHEST X-RAY ORDERED. COMPLETE PNEUMOTHORAX NOTED. RIGHT THORACOTOMY PERFORMED. NO AIR LEAK NOTED. CHEST TUBE REMAINED TO SUCTION. PT DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATRIUM MEDICAL CORP ATS BAG COMPATIBLE WATER SEAL CHEST DRAIN KDQ ATRIUM MEDICAL CORP. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R CHEST TUBES.