BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORS-100N SOLUTION WARMER DRAPE

    MDR report key: 5729293 · Received June 16, 2016

    Report

    Report Number
    8043817-2016-00034
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ASSOCIATED WITH ITEM NUMBER OM-ORS-100, LOT NUMBER 1052213 AND IS ASSOCIATED WITH THE POTENTIAL FOLLOWING ORS-100N NON STERILE MICROTEK LOT NUMBERS, D153021, D151621A, D152941, D151971, D151751, D151611, D151341, D153081A, D152761A, D153081, D153071, D153091, D153011, D153011A, AND D152891. NO DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE DEVICE HISTORY RECORD REVIEW, THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. SINCE A SAMPLE WAS NOT PROVIDED, THE NON-CONFORMITY COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    SURGEON STATES THERE IS A LEAK IN SOME OF THE DRAPES. HE HAS FOUND A SMALL AMOUNT OF FLUID (LESS THAN 50CC) BETWEEN THE DRAPE AND FLUID WARMER IN TWO CASES. HE IS CONCERNED THERE IS A BREAK IN STERILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385725 ORS-100N SOLUTION WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other