BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMAVE

    MDR report key: 940106 · Received November 6, 2007

    Report

    Report Number
    940106
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Date of Event
    October 31, 2007
    Report Date
    November 6, 2007
    Manufacturer
    PATTERSON MEDICAL
    Product Code
    KTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED IONTOPHORESIS TREATMENT TO LEFT ARM. THE MEDICATION USED WAS DEXAMETHAZONE 4MG/ML. THE SKIN WAS PREPPED PER MANUFACTURING RECOMMENDATIONS. CLEANED UNDER BOTH THE DISPERSIVE AND TREATMENT SITES WITH THE SUPPLIED ALCOHOL PREP PAD, AND ALLOWED TO DRY. THE SETTINGS USED WERE 70MA AT 2.5 CURRENT. WHEN DISPOSABLE PAD WAS REMOVED A BLISTER WAS NOTED. SKIN IRRITATION RESOLVED WITH NO ADDITIONAL TREATMENT NEEDED. CLINICAL ENGINEERING ASSESSED THE MACHINE AND DID NOT IDENTIFY A MALFUNCTION. SECOND OF TWO RECENT INCIDENTS WITH 2 DIFFERENT THERAPISTS INVOLVED. PACKAGING WAS NOT SAVED BUT THE BOX THE PAD WAS TAKEN FROM WAS. THE MACHINE WAS RETURNED TO THE COMPANY THROUGH THE SALES REP, AND ALL OF THE CURRENT STOCK OF ELECTRODES WAS SWITCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFORMAVE ELECTRODES, IONTOPHORESIS KTB PATTERSON MEDICAL 5543-11 10909

    Patients

    Seq Age Sex Outcome Treatment
    1 *