BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM MEDICAL CORP

    MDR report key: 271412 · Received March 28, 2000

    Report

    Report Number
    MW1018517
    Event Type
    Injury
    Date Received
    March 28, 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
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE TO RIGHT SIDE TO SUCTION DUE TO COMPLETE SPONTANEOUS RIGHT PNEUMOTHORAX. TWO DAYS LATER THE CHEST TUBE WAS PLACED TO WATER SEAL. CXR TAKEN 4 HRS LATER AND TUBE PLACED BACK TO SUCTION. TWO DAYS LATER AT 0400 THE CT WAS PLACED TO WATER SEAL DUE TO MD ORDER. CXR WAS DONE AT 0800. AT 1155 MD NOTES NO OBVIOUS AIR LEAK BUT LUNG DROPPED 20% ON WATER SEAL - BACK TO SUCTION. TWO DAYS LATER TO UNDERWATER SEAL. ONE DAY LATER SMALL AIR LEAK NOTED. CHEST TUBE TO SUCTION. FOLLOWING DAY THORACOSCOPY WITH BLEB RESECTION. CHEST TUBE TO SUCTION. THE SAME DAY CHEST TUBE TO WATER SEAL. BACK TO SUCTION AFTER 1 HR. TWO DAYS LATER CHEST TUBE TO WATER SEAL. 2000 CHEST TUBE REMOVED AT 0925. NO AIR LEAK NOTED. THE FOLLOWING DAY 1040 30-40% PNEUMOTHORAX NOTED ON CXR. TO OR AT 1130 FOR CHEST TUBE PLACEMENT. CHEST TUBE TO SUCTION. TWO DAYS LATER CHEST TUBE TO WATER SEAL.

    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 26 YR Hospitalization| R CHEST TUBES.