BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRATEMP THERMABASIN DRAPE

    MDR report key: 8831335 · Received July 26, 2019

    Report

    Report Number
    1043549-2019-40002
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 17, 2019
    Manufacturer
    HAYWOOD VOCATIONAL OPPORTUNITIES
    Product Code
    LHC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE, A HOLE WAS OBSERVED IN THE CORNER OF TWO DRAPES. THERE WAS NO HOLE ON THE OUTSIDE OF PACKAGING. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624304 INTRATEMP THERMABASIN DRAPE FLUID WARMING & SLUSH DRAPES LHC HAYWOOD VOCATIONAL OPPORTUNITIES ITB100 79059

    Patients

    Seq Age Sex Outcome Treatment
    1