BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O.R. SOLUTIONS INC.

    MDR report key: 116611 · Received August 28, 1997

    Report

    Report Number
    116611
    Event Type
    Malfunction
    Date Received
    August 28, 1997
    Date of Event
    August 25, 1997
    Report Date
    August 27, 1997
    Manufacturer
    O.R. SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERILE EQUIPMENT DRAPE FOR SLUSH MACHINE HAD A LEAK WHICH RESULTED IN APPROX. 40 CC OF FLUID IN BOTTOM OF BASIN, (BREAK IN A SEPTIC TECHNIQUE) APPROPRIATE ANTIBIOTIC THERAPY ORDERED. DURING OPEN HEART PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 O.R. SOLUTIONS INC. SOLUTION DRAPE - EQUIPMENT KKX O.R. SOLUTIONS, INC. 188231 DL090196

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other