BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONICATOR PLUS 994

    MDR report key: 3124034 · Received May 16, 2013

    Report

    Report Number
    2013558-2013-00003
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 29, 2013
    Manufacturer
    METTLER ELECTRONICS CORP.
    Product Code
    IPF
    PMA / PMN Number
    K984142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER (B)(6) (PHYSICAL THERAPIST) - PT WAS SEEN ON (B)(6) 2013 - FOR TREATMENT TO HIS DISTAL AND ANTERIOR RIGHT THIGH. HE REC'D INTERFERENTIAL ELECTRIC STIM, USING ALTERNATING CURRENT - SAFE MODE OF DELIVERY. PT INFORMED (B)(6), VIA PHONE CALL THE NEXT DAY THAT HE HAD SUSTAINED A BURN ON HIS RIGHT THIGH ARE WHERE THE E-STIM PAD WAS LOCATED. PT CAME IN TO THERAPY THREE DAYS LATER FOR HIS SCHEDULED PT RECHECK. PT'S BURN WOUND WAS ASSESSED IN PT AND HE WAS SENT OVER FOR MEDICAL CARE - WHICH HE REC'D FROM THE PHYSICIAN AS A ROUTINE PROCEDURE REGARDING BURNS. IT WAS DETERMINED TO BE A 1ST DEGREE BURN (SUPERFICIAL/REDNESS ONLY). PT IS FINE NOW - HE WAS DISCHARGED AND RELEASED FROM CARE AS PER THE TREATING PHYSICIAN. SINCE UNIT WAD PURCHASED, IT HAS NEVER BEEN IN TO METTLER ELECTRONICS FOR ANY SVS ISSUES. IT WAS LAST SERVICED BY PACE MEDICAL MAINTENANCE ON (B)(4) 2012. CONCENTRA IS TO RETURN UNIT TO METTLER (PER (B)(4)) A FOLLOW UP REPORT WILL BE ISSUED AFTER RECEIPT AND INSPECTION OF DEVICE AT METTLER ELECTRONICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216650 SONICATOR PLUS 994 ME994 IPF METTLER ELECTRONICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention