BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED WARMING SYSTEMS, INC

    MDR report key: 5695163 · Received June 2, 2016

    Report

    Report Number
    2936999-2016-00430
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 9, 2016
    Manufacturer
    COVIDIEN
    Product Code
    DWJ
    PMA / PMN Number
    K913016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE THAT THE WARM TOUCH BLANKET ADHESIVE HURT THE PATIENT. THE PATIENT SKIN WAS REPORTED TO BE RED FROM THE TAPE AND THE REDNESS AREA WAS TREATED WITH RIOHEX DEGERMANTE (A TOPICAL ANTISEPTIC). IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348741 ADVANCED WARMING SYSTEMS, INC WT CAREDRAPE UPPER DWJ COVIDIEN 5030870 153410011X

    Patients

    Seq Age Sex Outcome Treatment
    1