BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2722764 · Received April 26, 2012

    Report

    Report Number
    3003120375-2012-00379
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 26, 2012
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD.
    Product Code
    OMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS SELF REPORT FROM A (B)(6) FEMALE PT FROM THE UNITED STATES: (B)(4). INITIAL INFORMATION WAS PROCESSED WITH ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012. THE PT'S HEIGHT WAS (B)(6) AND WEIGHT WAS (B)(6). THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED HYSTERECTOMY AND NO REACTION ON PREVIOUS EXPOSURE TO PRODUCT AS SHE "ALWAYS USED THE PRODUCT FOR HER BACK AND SHOULDER PAIN." THE PT HAD NO KNOWN NON DRUG ALLERGIES. THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (TOPICAL, BATCH (B)(4)) ONE PATCH AS NEEDED INITIATED ON AN UNSPECIFIED DATE TO (B)(6) 2012 FOR BACK AND SHOULDER PAIN. CONCOMITANT MEDICATIONS INCLUDED PREMARIN (ESTROGENS CONJUGATED) (FORMULATION, ROUTE, DOSAGE UNSPECIFIED) ONE PER DAY FOR TWO YEARS INITIATED IN 2010 FOR HORMONE REPLACEMENT. ON (B)(6) 2012, WHEN THE PT REMOVED THE PATCH FROM HER SHOULDER, THE ADHESIVE TAPE PULLED HER SKIN OFF AND MADE HER BLEED. THE APPLICATION SITE WAS A "GREENISH COLOR" AND HURT. THE PT FURTHER DESCRIBED HER SHOULDER AS "LOOKING REALLY BAD AS IF IT WAS A SECOND DEGREE BURN." ALSO, THE PT HAD A "BIG SCAB." THE PT DID NOT TREAT HERSELF NOR WAS SEEN IN THE EMERGENCY ROOM. THE PT NOTED THAT THE ADHESIVE TAPE/GLUE WAS TOO STRONG (PRODUCT QUALITY ISSUE). TREATMENT WITH PRECISE PAIN RELIEVING HEAT PATCH WAS WITHDRAWN. THE PT HAD NOT RECOVERED FROM THE EVENTS. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (MALFUNCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PAIN RELIEVING HEAT PATCH NONE OMW KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD. UNK BJC034

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other HORMONE REPLACEMENT THERAPY, 1 DOSE(S), 1 IN 1 DAY| UNKNOWN ??/??/2010 - ONGOING| PREMARIN (ESTROGENS CONJUGATED) UNKNOWN