BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WELL AT WALGREENS

    MDR report key: 6418730 · Received March 20, 2017

    Report

    Report Number
    1460851-2017-00008
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 20, 2017
    Manufacturer
    BIG WALL ENTERPRISES
    Product Code
    IMA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE BOUGHT A HEATING WRAP FROM A (B)(6) STORE ABOUT A YEAR AGO. SHE PUT THE HEATING WRAP IN HER MICROWAVE AND SET THE ALLOTTED TIME AND REMOVED IT. THE CUSTOMER DID NOT FEEL IT WAS WARM ENOUGH SO SHE PUT IT BACK IN THE MICROWAVE FOR MORE TIME AND THEN PUT IT ON HER SHOULDER. SHE SAID STUFF FROM THE WRAP WAS HEATING HER BACK, CHEST AND WRIST. SHE REPORTED THAT SHE WENT TO THE ER, AND FOLLOWED UP WITH THE DOCTOR WHO INDICATED THAT THE BURN SHOULD HEAL WITHOUT ANY FURTHER ISSUES. THE CUSTOMER DOES NOT HAVE A UPC OR WIC. WE DO NOT HAVE INFORMATION TO CONFIRM THE ALLEGATIONS AS THERE IS NOT PROOF THAT THE ITEM WAS PURCHASED AT ANY (B)(6) STORE, THE CUSTOMER DOES NOT HAVE ANY WIC NUMBER THAT CAN BE TIED TO OUR PRODUCTS. BASED ON THE INFORMATION PROVIDED, WE ASSUME IT WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201563 WELL AT WALGREENS HOT / COLD CLAY WRAP BACK IMA BIG WALL ENTERPRISES

    Patients

    Seq Age Sex Outcome Treatment
    1 Other