BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE

    MDR report key: 4377235 · Received December 16, 2014

    Report

    Report Number
    4377235
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    December 5, 2014
    Report Date
    December 16, 2014
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    MUI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS WAITING IN THE EMERGENCY ROOM, THE COMPRESS SHE HAD BEEN GIVEN BURST AND LEAKED. PATIENT INFORMED NURSING STAFF THAT SHE HAD BEEN BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826445 MEDICHOICE INSTANT COLD PACK MUI OWENS & MINOR DISTRIBUTION, INC. 69904 *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR