BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM MEDICAL CORP.

    MDR report key: 271414 · Received March 28, 2000

    Report

    Report Number
    MW1018518
    Event Type
    Injury
    Date Received
    March 28, 2000
    Date of Event
    March 6, 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 EVALUATED AFTER A GO-CART ACCIDENT. A 10% PNEUMOTHORAX WAS DIAGNOSED. MD ELECTED TO HAVE PT RETURN FOR CHEST X-RAY. PT DID NOT SHOW UP. TWO DAYS LATER CHEST TUBE PLACED TO WATER SUCTION. CHEST TUBE DISCONTINUED AND PT SENT HOME. THREE DAYS LATER PT PRESENTED TO MD OFFICE WITH INCREASED CHEST PAIN, CXR SHOWED 20-40% RIGHT PNEUMOTHORAX. RIGHT CHEST TUBE PLACED TO SUCTION. TWO DAYS LATER CHEST TUBE TO WATER SEAL. THE NEXT DAY CHEST TUBE DISCONTINUED IN THE MORNING AND AT 1750, CHEST TUBE REPLACED TO SUCTION. TWO DAYS LATER TO OR FOR RIGHT THORACOSCOPY OF BLEB RESECTION, CHEST TUBE TO SUCTION. TWO DAYS LATER CHEST TUBE TO WATER SEAL FOR 1 HR, THEN HAD TO BE PLACED BACK TO SUCTION. TWO DAYS LATER CHEST TUBE TO WATER SEAL. TWO DAYS LATER CHEST TUBE CLAMPED AND THEN REMOVED LATER THAT DAY. THE NEXT DAY PT DISCHARGED HOME. SURGEON REPORTED TEN DAYS LATER THEY BELIEVED THE WATER SEAL CHEST DRAIN SYSTEM CAUSED PROBLEMS BECAUSE OF THE PT'S COURSE OF TREATMENT.

    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 22 YR Hospitalization| R