BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A-TRAUM CHEST TUBE, SILICONE, WITH CLOTSTOP

    MDR report key: 14733 · Received July 18, 1994

    Report

    Report Number
    MW1002852
    Event Type
    Injury
    Date Received
    July 18, 1994
    Date of Event
    July 7, 1994
    Report Date
    July 8, 1994
    Manufacturer
    AXIOM MEDICAL, INC.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CHEST TUBE PLACED PER ROUTINE (HAVE USED PRODUCT FOR YRS), SNAPPED OFF AT TIP; CONTINUED WITH PLACEMENT. WHILE PT BEING ADMITTED TO ICU POST-OP, CHEST TUBE NOTED TO HAVE "SNAPPED" OFF COMPLETELY, TUBE MUCH MORE FRIABLE THAN USUAL PRODUCTS. 7/7/94, PT RETURNED TO OR FOR REPLACEMENT OF CHEST TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 A-TRAUM CHEST TUBE, SILICONE, WITH CLOTSTOP Implant CHEST TUBE, SILICONE WITH CLOTSTOP KDQ AXIOM MEDICAL, INC. 100020AT 9405854

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Other| R REPAIR OF TETRALOGY OF FALLOT