BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6046203 · Received October 20, 2016

    Report

    Report Number
    1460851-2016-00005
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    October 20, 2016
    Manufacturer
    BIGWALL ENTERPRISES
    Product Code
    IME
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HER HUSBAND USED THE HOT/COLD WRAP ON HIS ARM AND THE SIDE OF THE WRAP OPENED CAUSING THE INTERIOR CONTENTS TO SPILL ON HIS ARM. REPORTER INDICATED THAT HER HUSBAND HAD HAD SURGERY PRIOR TO THIS INCIDENT AND THE INCIDENT MADE THE WOUND WORSE. THE MANUFACTURER IS FOLLOWING UP TO INVESTIGATE THE INCIDENT AND DETERMINE IF THE CONSUMER SOUGHT MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696964 WELL AT WALGREENS HOT/COLD CLAY WRAP IME BIGWALL ENTERPRISES 11182015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other