BEUDAMED
    FDA Adverse Event Summary report: N

    ECOLAB

    MDR report key: 5616498 · Received April 28, 2016

    Report

    Report Number
    1047429-2016-00012
    Date Received
    April 28, 2016
    Date of Event
    February 22, 2016
    Report Date
    April 28, 2016
    Manufacturer
    ECOLAB
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL, AN OWENS & MINOR COMPANY, IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS SLUSH DRAPE 66X52, PART # ORS-321N MANUFACTURED BY ECOLAB. ECOLAB RECEIVED A COMPLAINT ON(B)(6) 2016 AND THEN NOTIFIED AVID MEDICAL OF THE COMPLAINT ON 04-14-2016. THIS COMPLAINT WAS ORIGINATED BY (B)(6), ASST. MGR. CARDIO SURGERY, (B)(6) MEDICAL CENTER STATING THAT AFTER THE CASE WAS DONE, A TEAR WAS DISCOVERED IN THE SLUSH DRAPE. THE DRAPE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE SLUSH DRAPE-PART NO. ORS-321N. THE SLUSH DRAPE USED IN THE MEDICAL PROCEDURE TRAY CAME FROM LOTS #D153091; D152651.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273810 ECOLAB SLUSH DRAPE LHC ECOLAB ORS-321N D153091; D152651

    Patients

    Seq Age Sex Outcome Treatment
    1