BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE, SLUSH DRAPES

    MDR report key: 7553161 · Received May 29, 2018

    Report

    Report Number
    MW5077505
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    May 21, 2018
    Report Date
    May 24, 2018
    Manufacturer
    ECOLAB INC.
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT TO OPERATING ROOM FOR SURGICAL PROCEDURE. AFTER SURGERY, DURING CLEAN-UP, IT WAS NOTED THAT THERE WAS A HOLE IN THE WARMER DRAPE. POSSIBLE CONTAMINATION ISSUE. THERAPY START DATE: (B)(6) 2018; THERAPY END DATE: (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393536 WARMER DRAPE, SLUSH DRAPES WARMER IRRIGATION SOLUTION LHC ECOLAB INC. D180329

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other