BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INC.

    MDR report key: 8759992 · Received July 3, 2019

    Report

    Report Number
    2411236-2019-00004
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 13, 2019
    Report Date
    June 13, 2019
    Manufacturer
    INTCO MEDICAL (HK) CO, LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CLAIMS THE COLD PACK LEAKED ONTO HER SKIN, CAUSING A REACTION AND BLISTERING TO DEVELOP. THE PATIENT USED THE COLD PACK AT HOME. THE DR. TOOK A BACTERIAL CULTURE OF THE WOUND AND THE PATIENT WAS PRESCRIBED MUPIROCIN CREAM AND 500MG CIPROFLOXACIN. THE PATIENT WAS REPORTED TO BE DOING WELL AND THERE WERE NO NEW SYMPTOMS SINCE THE LAST VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553545 HENRY SCHEIN INC. INSTANT COLD PACK, DISPOSABLE IMD INTCO MEDICAL (HK) CO, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other