BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PAIN RELIEVING HEAT PATCH

    MDR report key: 2120131 · Received June 3, 2011

    Report

    Report Number
    3003120375-2011-00146
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 6, 2011
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO, LTD
    Product Code
    IMD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS REC'D FROM A (B)(6) YEAR OLD FEMALE PT REPORTING ON HERSELF FROM THE UNITED STATES (B)(6). THE PT'S WEIGHT WAS (B)(6) POUNDS. THE PT'S MEDICAL HISTORY INCLUDED NO KNOWN ALLERGIES AND NO MEDICAL HISTORY. THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH, APPLIED ONCE TOPICALLY, INITIATED ON (B)(6) 2011 FROM APPROX 2:00 PM TO 3:30 PM FOR BACK PAIN. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, AFTER WEARING THE PATCH FOR A HOUR AND A HALF, THE PT EXPERIENCED DIFFICULTY IN REMOVING THE PATCH. ACCORDING TO THE PT, THE PATCH TORE OFF HER SKIN AND IT WAS PINK. SHE REPORTED THAT HER SKIN WAS "ON THE PATCH" AND IT LEFT 6 LINES ON HER SKIN. AT THAT TIME SHE WAS "PANICKING" AND DID NOT KNOW WHAT TO DO. SHE DID NOT CONTACT HER DOCTOR, BUT DID SHOW THE PHARMACIST AT WORK. ACTION TAKEN WITH THE PATCH WAS DISCONTINUED. THE PT HAD NOT RECOVERED FROM THE EVENTS. 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 BHC003

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other