BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYS STIM ME220

    MDR report key: 3001714 · Received March 8, 2013

    Report

    Report Number
    2013558-2013-00001
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    March 1, 2012
    Report Date
    March 7, 2013
    Manufacturer
    METTLER ELECTRONICS CORP.
    Product Code
    LIH
    PMA / PMN Number
    K883080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2013 I RECEIVED A CALL FROM (B)(6) - SHE STATED THAT A MALE PT WAS TREATED WITH AN ME220 (MUSCLE STIMULATOR) ON THREE DIFFERENT OCCASIONS ((B)(6) 2012). ALLEGEDLY UPON THE THIRD VISIT ((B)(6) 2012) IT WAS NOTICED THAT THE PT HAD A SMALL (3RD DEGREE) BURN - ABOUT THE SIZE OF A CIGARETTE ON HIS BACK (HE WAS BEING TREATED FOR BACK INJURIES DUE TO AN AUTOMOBILE ACCIDENT). THERE ARE NO PICTURES OF ALLEGED BURN. THE PT LEFT THE OFFICE AND NOTHING MORE HAPPENED - UNTIL NOW, ALMOST ONE YEAR LATER, WHEN THE PT HAS NOW OBTAINED A LAWYER AND IS ALLEGEDLY FILING A LAWSUIT AGAINST (B)(6). SINCE THE ALLEGED INCIDENT, (B)(6)HAS CONTINUED TO USE SAID DEVICE AND HAS HAD NO ISSUES. UPON NOTIFICATION OF THE LAWSUIT, METTLER INSTRUCTED (B)(6) TO SUBMIT THE DEVICE TO METTLER FOR INVESTIGATION - THUS THE DEVICE WAS RECEIVED AT METTLER ON (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99996 SYS STIM ME220 MUSCLE STIMULATOR LIH METTLER ELECTRONICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention