BEUDAMED
    FDA Adverse Event Summary report: N

    ECOLAB

    MDR report key: 5733379 · Received June 17, 2016

    Report

    Report Number
    1047429-2016-00017
    Date Received
    June 17, 2016
    Date of Event
    May 19, 2016
    Report Date
    June 21, 2016
    Manufacturer
    ECOLAB
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL, AN OWENS & MINOR COMPANY, IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS DRAPE,ORS WARMING 44"X44" POLY, PART # ORS-100N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON 05/26/2016 ORIGINATED BY (B)(6), OPERATING ROOM (OR) OFFICE CLERK, (B)(6) HOSPITAL STATING THAT THE SURGEON NOTED 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. THE COMPLAINT IDENTIFIED 2 DRAPES, SO THIS IS MDR # 2 OF 2 ORIGINATING WITH THIS COMPLAINT. THE COMPLAINED DRAPES WERE NOT AVAILABLE FOR EVALUATION. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB FOR A LEAK IN WARMING DRAPE NO. ORS-100N. THE DRAPE LOT # ARE AS FOLLOWS: D151621ARHVO, D151751RHVO,D153071, D153081, D153011, D153021, D151341, D153081A, D153091, D152891, D153011A, D151971RHVO, D151611RHVO, D152941, D152761A. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388588 ECOLAB WARMER DRAPE LHC ECOLAB ORS-100N D151621ARHVO,D151751RHVO

    Patients

    Seq Age Sex Outcome Treatment
    1