BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE INSTANT WARM COMPRESS

    MDR report key: 8586078 · Received May 7, 2019

    Report

    Report Number
    8586078
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    February 20, 2019
    Report Date
    February 21, 2019
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC
    Product Code
    IME
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    POTENTIAL RISK TO PATIENTS USING MEDICHOICE INSTANT WARM COMPRESS. THE COMPRESS, EVEN WHEN USED AS DIRECTED (I.E.-IN THE PROTECTIVE SLEEVE PROVIDED BY THE MANUFACTURER), MAY CAUSE REDNESS AND DISCOMFORT WHEN APPLIED TO AFFECTED AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379147 MEDICHOICE INSTANT WARM COMPRESS PACK, HOT OR COLD, REUSEABLE IME OWENS & MINOR DISTRIBUTION, INC

    Patients

    Seq Age Sex Outcome Treatment
    1