BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS

    MDR report key: 3731814 · Received April 2, 2014

    Report

    Report Number
    MW5035473
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    February 22, 2014
    Report Date
    April 1, 2014
    Manufacturer
    PHILIPS
    Product Code
    FOH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BLISTERS TO BACK AND POSTERIOR RIGHT THIGH IN HONEYCOMB PATTERN NOTED IMMEDIATELY AFTER REMOVAL OF INNERCOOL PADS USED FOR HYPOTHERMIA PROTOCOL. DATES OF USE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199949 PHILIPS PAD FOH PHILIPS 081-CB-00036

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR