BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOPOLAR CORD

    MDR report key: 1730104 · Received June 18, 2010

    Report

    Report Number
    1530493-2010-00004
    Event Type
    Other
    Date Received
    June 18, 2010
    Report Date
    June 17, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K971540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A SEPARATE INCIDENT FROM OUR REPORT NUMBER 1530493-2010-00003. THE INFO CONCERNING 1530493-2010-00003 AND 1530493-2010-00004 WAS SENT IN THE SAME COMMUNICATION FROM THE END-USER AT THE SAME TIME. THE USER FACILITY WAS QUESTIONED ABOUT THIS EVENT, AND IT WAS COMMUNICATED TO OLSEN MEDICAL THAT "THE TIME WE HAD AN ACTUAL FLAME FROM A CORD, WE GAVE BIOMED ALL THE PARTS, THEY COULDN'T DETERMINE MUCH." THE EVENT DATE WAS NOT DETERMINABLE AND THE LOT NUMBER WAS NOT PROVIDED. THE USER FACILITY STATED THAT "BECAUSE THERE WAS NO PT INJURY, THE EVENT WAS NOT MDR REPORTABLE, SO THE FACILITY THREW THE DEVICE AWAY."

    Description of Event or Problem · 1

    THE EVENT WAS DESCRIBED IN A COMMUNICATION FROM THE END-USER. IN OUR MANUFACTURER REPORT NUMBER 1530493-2010-00003, THE COMMUNICATION FROM THE USER FACILITY TO OLSEN MENTIONED AN EVENT SOMETIME IN THE PAST WHERE A CORD CAUGHT FIRE AT THE POINT WHERE THE CORD MEETS THE MOLDED PLASTIC PLUG. THERE WAS NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CORD REUSABLE MONOPOLAR CORD GEI OLSEN MEDICAL 90056 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other