BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2000777 · Received February 16, 2011

    Report

    Report Number
    3003120375-2011-00002
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS/ LABORATORY TESTING. THEREFORE, NO CAUSAL ASSOCIATION OR CONCLUSION CAN BE DETERMINED.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A (B)(6) FEMALE CONSUMER REPORTING ON HERSELF. THE CONSUMER REPORTED APPLYING ONE PRECISE PAIN RELIEVING HEAT PATCH (NO ACTIVE INGREDIENT) AS NEEDED FOR SHOULDER AND BACK PAIN (DATES UNSPECIFIED). SHE APPLIED THE PRODUCT DIRECTLY ON HER SKIN WITHOUT A LAYER OF PROTECTIVE CLOTHING. THE CONSUMER ALSO TOOK IMITREX (SUMATRIPTAN SUCCINATE) (NON-COMPANY DRUG) AS NEEDED FOR PAIN (DOSE, FREQUENCY, AND DATES UNSPECIFIED). ON AN UNSPECIFIED DATE, AFTER PRODUCT USE, SHE HAD SORES ON HER BACK. ON (B)(6) 2011, AFTER PRODUCT USE ON HER LEFT SHOULDER, AS SHE REMOVED THE PRODUCT, HER SKIN CAME OFF ALONG WITH THE PATCH. THE CONSUMER HAD A LOT OF PAIN AND BURNING AS HER SHOULDER HAD BLISTERS THAT TURNED INTO RED WELTS. ON (B)(6) 2011, USE OF THE PATCH HAS DISCONTINUED. AS OF (B)(6) 2011, USE OF IMITREX WAS CONTINUED, THE OUTCOME OF THE SORES ON HER BACK WAS RESOLVED, AND THE OUTCOME OF THE OTHER EVENTS WAS REPORTED AS NOT RESOLVED. THIS CASE IS SERIOUS (MEDICALLY SIGNIFICANT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PAIN RELIEVING HEAT PATCH PACK, HOT OR COLD, DISPOSABLE IMD KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD 1001202

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other