BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METTLER

    MDR report key: 119474 · Received September 11, 1997

    Report

    Report Number
    MW1012074
    Event Type
    Malfunction
    Date Received
    September 11, 1997
    Date of Event
    June 25, 1997
    Report Date
    July 7, 1997
    Manufacturer
    METTLER ELECTRONICS CORP.
    Product Code
    IPF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING ESTEM TREASTMENT. 3 AREAS HAD BEEN TREATED - WHEN MACHINE HEAD APPLIED TO 4TH AREA (R L Q OF BACK) PT COMPLAINING OF BURNING AND SUPERFICIAL NUMBNESS OF SKIN. PCP SAW PT. SILVADENE OINTMENT APPLIED TO SLIGHTLY REDDENED AREA ON BACK. PT. RESUMED TX. 6-30-97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METTLER ELECTRICAL STIMULATOR (DOP 2-93) IPF METTLER ELECTRONICS CORP. SYS STEM ULTRASOUND *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other