BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRECISE PAIN RELIEVING PATCH

    MDR report key: 2417645 · Received January 11, 2012

    Report

    Report Number
    1054358-2012-00001
    Event Type
    Other
    Date Received
    January 11, 2012
    Date of Event
    December 14, 2011
    Report Date
    January 10, 2012
    Manufacturer
    KIRIBAI KOBAYASHI PHARMACEUTICAL CO LTD
    Product Code
    IMD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST REPORT MEDIHEAT HAS RECEIVED, IN FOUR YEARS OF PRODUCING THE DIRECT SKIN PRODUCT, OF AN IGNITION (A PATCH CATCHING FIRE). THE PRODUCT INVOLVED HAS BEEN REQUESTED FROM THE PT FOR A FULL EVAL. WE HAVE CONDUCTED A FULL QUALITY REVIEW OF ALL RECORDS AND HAVE CONFIRMED THAT THIS LOT MEETS ALL PRODUCT SPECS, AND THAT THERE IS NO EVIDENCE OF ANY NON-CONFORMANCE OR ABNORMALITIES IN THE MANUFACTURE OF THIS LOT. WE HAVE CURRENTLY NOT RECEIVED THE WARMER AT ISSUE, DESPITE THE PT'S AGREEMENT TO SEND THE WARMER. DUE TO THE NATURE OF THIS DEVICE, WE FEEL IT IS VERY UNLIKELY AND HIGHLY IMPROBABLE THAT THIS DEVICE COULD IGNITE. WE WILL COMPLETE OUR INVESTIGATION IF WE RECEIVE THE WARMER FROM THE PT, AND DETERMINE THE FACTORS THAT COULD HAVE CAUSED THE ALLEGED IGNITION. IF WE DO NOT HEAR BACK FROM THE PT, WE WILL CLOSE THE INVESTIGATION AND NOTIFY THE FDA.

    Description of Event or Problem · 1

    THIS WAS A SPONTANEOUS REPORT FROM A FEMALE OF AN UNSPECIFIED AGE FROM THE UNITED STATES: (B)(4). THE PT'S HEIGHT, WEIGHT AND MEDICAL HISTORY ARE UNSPECIFIED. THE PRECISE PAIN RELIEVING PATCH WAS APPLIED TO THE PT FOR "4 - 5 HOURS LAYING ON THE SOFA." THE PT THEN REPORTED THE "PATCH BURNED IN ONE SPOT AND I REMOVED. PATCH WAS ACTUALLY ON FIRE." THE PT STATED THAT THE ONLY INJURY WAS A "VERY VERY SMALL BURN ON MY BACK." MEDIHEAT, INC RECEIVED THE INITIAL REPORT ON 12/15/2011, AND RECEIVED PT AND LOT INFO ON 12/22/2011. THE PT WAS CONTACTED ON 12/22/2011 TO HAVE THE PRODUCT RETURNED FOR EVAL AND TESTING. THE PT RESPONDED ON 12/25/2011, THANKING US FOR THE QUICK RESPONSE AND NOTIFYING US THAT SHE WOULD SEND THE PRODUCT BACK THE FOLLOWING WEEK. AT THIS TIME MEDIHEAT INC, HAS NOT RECEIVED THE PRODUCT WITH THE ALLEGED IGNITION TO BE ABLE TO DETERMINE THE VALIDITY OF THE ALLEGATION. WE WILL ATTEMPT TO CONTACT THE PT ONE MORE TIME FOR ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE PAIN RELIEVING PATCH NONE IMD KIRIBAI KOBAYASHI PHARMACEUTICAL CO LTD BDC005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other