BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2586890 · Received May 22, 2012

    Report

    Report Number
    3003120375-2012-00465
    Event Type
    Injury
    Date Received
    May 22, 2012
    Report Date
    May 14, 2012
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD
    Product Code
    OMW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A PHYSICIAN VIA A COMPANY REP AND CONCERNED A PT OF AN UNSPECIFIED AGE AND SEX FROM THE UNITED STATES: (B)(4). THE PT'S HEIGHT, WEIGHT, AND MEDICAL HISTORY WERE NOT REPORTED. THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (TOPICAL, DOSAGE AND FREQUENCY UNSPECIFIED) INITIATED ON AN UNSPECIFIED DATE FOR AN UNSPECIFIED INDICATION. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, "THE PRODUCT CAUSED THE PT'S SKIN TO BURN." ACTION TAKEN WITH PRECISE PAIN RELIEVING HEAT PATCH WAS UNSPECIFIED. THE PT OUTCOME WAS UNSPECIFIED FOR SKIN BURN. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (SERIOUS INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PAIN RELIEVING HEAT PATCH ADHESIVE BACKED THERMAL SKIN PATCHES OMW KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other