BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 7143844 · Received December 22, 2017

    Report

    Report Number
    2411236-2017-00004
    Event Type
    Injury
    Date Received
    December 22, 2017
    Date of Event
    September 13, 2017
    Report Date
    November 29, 2017
    Manufacturer
    SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTS THAT SHE SUSTAINED BURNS ON HER LEFT SHOULDER AFTER THE COLD PACK WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922136 HENRY SCHEIN COLD COMPRESS INSTANT IMD SHANGHAI INTCO MEDICAL SUPPLY CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other