BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM MEDICAL, INC

    MDR report key: 155512 · Received February 6, 1998

    Report

    Report Number
    155512
    Event Type
    Malfunction
    Date Received
    February 6, 1998
    Date of Event
    August 8, 1997
    Report Date
    February 6, 1998
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHEST TUBES REMOVED PER PROTOCOL. PROCEDURE WENT WELL AND PT TOLERATED WELL BY PT. HOWEVER, RIGHT CHEST TUBE NOTED TO BE SEVEN INCHES SHORTER THAT LEFT WITH JAGGED EDGES. PORTABLE X-RAY OBTAINED. PHYSICIAN SPOKE WITH WHO DIDN'T WANT THE TUBING REMOVED. RISKS, ALTERNATIVES AND POTENTIAL COMPLICATIONS EXPLAINED TO PT. PT STILL REFUSED ANY INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM MEDICAL, INC CHEST TUBE KDQ AXIOM MEDICAL, INC. 11075 AT 9702023 MIC15551,(MORE)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other