BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1002960 · Received September 25, 2007

    Report

    Report Number
    8030647-2007-00120
    Event Type
    Other
    Date Received
    September 25, 2007
    Date of Event
    April 25, 2007
    Report Date
    September 25, 2007
    Manufacturer
    *
    Product Code
    DWJ
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY WAS ASKED TO RETURN THE THERMAL PADS. QUESTIONS WERE ASKED OF THEM REGARDING THE INCIDENT. THE USER FACILITY THEN CALLED STATING THEY CONSIDERED THE CONTROL UNIT AND NOT THE PADS, TO BE THE CAUSE OF THE INCIDENT. THE PADS WERE NOT RETURNED FOR EVALUATION. THE UNIT RETRIEVED FROM THE HOSP WAS ASSOCIATED WITH ANOTHER INCIDENT REPORT (MDR 8030647-2007-00108) FROM THE SAME FACILITY. THE UNIT WAS EVALUATED AND DETERMINED TO HAVE NO ANOMALIES, ERRORS OR INCONSISTENCIES. THE ONLY MEDICAL INTERVENTION CITED WAS THE USE OF SILVADENE CREAM ON THE BURN. SKIN INJURY CAN OCCUR AS A CUMULATIVE RESULT OF PRESSURE, TIME AND TEMPERATURE.

    Description of Event or Problem · 1

    KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED, BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY MEDWATCH WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATA BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * DWJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *