BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2181390 · Received July 21, 2011

    Report

    Report Number
    3003120375-2011-00353
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 21, 2011
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO., LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A CONSUMER CONCERNING HIS (B)(6) WIFE FROM (B)(6): (B)(4). THE PT'S HEIGHT WAS (B)(6). THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED: HYPERTENSION AND SULFA ALLERGY. IN THE MORNING OF (B)(6) 2011, THE PT APPLIED PRECISE PAIN RELIEVING HEAT PATCH TO AN UNSPECIFIED AREA OF THE BODY. CONCOMITANT MEDICATIONS INCLUDED HCTZ (HYDROCHLOROTHIAZIDE), DOSAGE UNSPECIFIED, INITIATED ON AN UNSPECIFIED DATE FOR HYPERTENSION. ON (B)(6) 2011, FOUR HOURS AFTER THE PATCH WAS APPLIED, THE PT COMPLAINED THAT THE PATCH WAS IRRITATING AND SHE DEVELOPED BLISTERS. THE PT REMOVED THE PATCH AND IT PEELED HER SKIN OFF AS WELL, CAUSING THE BLISTERS TO BECOME RAW. SHE WAS ALSO IN A LOT OF PAIN. THE PT CONSULTED A PHARMACIST REGARDING THE REPORTED EVENTS AND BEGAN TREATING THE BLISTERS WITH TRIPLE ANTI-BIOTIC. THE ACTION TAKEN WITH PRECISE PAIN RELIEVING HEAT PATCH WAS WITHDRAWN. AT THE TIME OF THE REPORTING, THE OUTCOME OF THE EVENTS WAS NOT RECOVERED. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PAIN RELIEVING HEAT PATCH NONE IMD KIRIBAI KOBAYASHI PHARMACEUTICAL CO., LTD. UNK BDC022

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other