BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATL CAMERA DRAPE (PRODUCT #2950-1153-01)

    MDR report key: 180881 · Received August 6, 1998

    Report

    Report Number
    1043582-1998-00004
    Event Type
    Malfunction
    Date Received
    August 6, 1998
    Report Date
    July 14, 1998
    Manufacturer
    MICROTEK MEDICAL
    Product Code
    KXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SALINE SOLUTION LEAKED OUT OF SEAM BETWEEN LATEX AND POLYETHYLENE SLEEVE. SALINE DRIPPED INTO PATIENTS CHEST CAVITY. CUSTOMER CLAIMS ONLY A SMALL AMOUT OF SALINE WAS USED AND THAT DRIPPING OCCURRED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATL CAMERA DRAPE (PRODUCT #2950-1153-01) ULTRA SOUND PROBE DRAPE KXX MICROTEK MEDICAL NA D8079R

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other