BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2108914 · Received May 26, 2011

    Report

    Report Number
    3003120375-2011-00154
    Event Type
    Injury
    Date Received
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD.
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A FEMALE PATIENT (AGE UNSPECIFIED) FROM THE UNITED STATES REPORTING ON HERSELF: (B)(6). THE PATIENT'S HEIGHT, WEIGHT AND MEDICAL HISTORY WERE UNSPECIFIED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (LOT# 1003043, EXPIRATION 28-FEB-2011, TOPICAL, FREQUENCY AND INDICATION UNSPECIFIED). ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A THIRD DEGREE BURN. SHE VISITED THE DOCTOR (DATES UNSPECIFIED) WHO "PUT HER ON AN (UNSPECIFIED) ANTIBIOTIC" AS TREATMENT. AT THE TIME OF REPORTING, THE ACTION TAKEN WITH THE PRODUCT WAS UNSPECIFIED AND THE PATIENT OUTCOME WAS UNSPECIFIED FOR THIRD DEGREE BURN. 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 1003043

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other