BEUDAMED
    FDA Adverse Event Summary report: N

    ECOLAB

    MDR report key: 5551459 · Received April 6, 2016

    Report

    Report Number
    1047429-2016-00010
    Date Received
    April 6, 2016
    Date of Event
    February 17, 2016
    Report Date
    April 6, 2016
    Manufacturer
    ECOLAB
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS A WARMER DRAPE PART # ORS-300N MANUFACTURED BY ECOLAB. AVID MEDICAL RECEIVED A COMPLAINT ON (B)(4) 2016 ORIGINATED BY (B)(6), STATING A HOLE IN THE WARMER DRAPE WAS NOTICED AT THE END OF THE CASE. THE DRAPE INVOLVED IN THE COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. NO PATIENT INJURY WAS REPORTED. AVID MEDICAL ISSUED FORMAL COMPLAINT (B)(4) TO THE MANUFACTURER ECOLAB FOR A HOLE IN THE WARMER DRAPE - PART # ORS-300N. THE WARMER DRAPE LOT # D151381RHVO; D152781; D152751.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206081 ECOLAB DRAPE, WARMER LHC ECOLAB ORS-300N D151381RHVO; D152781; D152751

    Patients

    Seq Age Sex Outcome Treatment
    1