BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM MEDICAL CORP

    MDR report key: 271408 · Received March 28, 2000

    Report

    Report Number
    MW1018516
    Event Type
    Injury
    Date Received
    March 28, 2000
    Date of Event
    January 31, 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

    PT WAS ADMITTED WITH A RIGHT TENSION PNEUMOTHORAX. A 24 F CHEST TUBE WAS PLACED. THE NEXT DAY CHEST X-RAY SHOWED 20% PNEUMOTHORAX. CHEST TUBE WAS REPLACED. TWO DAYS LATER THE CHEST TUBE STILL HAD AN AIR LEAK AND THE PT WENT TO OR FOR THORACOSCOPY AND EXCISION OF APICAL BLEB. CHEST TUBES WERE PLACED X 2 TO SUCTION. A WEEK LATER SMALL AIR LEAK DOCUMENTED. THE FOLLOWING DAY NO AIR LEAK AND CHEST TUBE PLACED TO WATER SEAL. THE NEXT DAY ONE CHEST TUBE WAS REMOVED. A DAY LATER SMALL APICAL PNEUMOTHORAX WAS NOTED AFTER REMOVAL OF THE 1ST CHEST TUBE. 2ND CHEST TUBE REMOVED. APPROXIMATELY 45 MINS LATER, PT WAS SHORT OF BREATH WITH 30% PNEUMOTHORAX. RIGHT CHEST TUBE PLACED TO SUCTION. TWO DAYS LATER CHEST TUBE TO WATER SEAL. THE NEXT DAY CHEST TUBE REMOVED AT 0900. PT DISCHARGED HOME AT 1700.

    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 24 YR Hospitalization| R SHERWOOD MEDICAL THORACIC CATHETER, 24 F.