BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTION PATCH SMART IONTOPHORESIS SYSTEM

    MDR report key: 1100907 · Received August 7, 2008

    Report

    Report Number
    2182686-2008-00001
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    July 10, 2008
    Manufacturer
    EMPI
    Product Code
    EGJ
    PMA / PMN Number
    K030395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED TO DATE SUGGESTS THAT THERE MAY HAVE BEEN AN INAPPROPRIATE SOLUTION USED DURING THE TREATMENT PROCEDURE AND THAT SOLUTION MAY HAVE CAUSED OR CONTRIBUTED TO THIS INJURY ASSOCIATED WITH THIS EVENT. THE INVESTIGATION OF THIS EVENT IS ONGOING, AND A SUPPLEMENTAL REPORT MAY BE SUBMITTED IF MATERIAL INFO IS DISCOVERED.

    Description of Event or Problem · 1

    PATIENT REPORTED RECEIVING A BURN WITH A BLISTER ON THE LATERAL SIDE OF THE LEFT FOOT AFTER IONTOPHORESIS TREATMENT. PATIENT SOUGHT MEDICAL ATTENTION FROM PODIATRIST AND REC'D TREATMENT FOR THE BURN INCLUDING PRESCRIPTION FOR BACTROBAN OINTMENT, XEROFORM APPLICATION ON HER FOOT. THE PODIATRIST'S ASSESSMENT STATED "QUESTIONABLE ALLERGIC REACTION TO THE IONTOPHORESIS PATCH" AND POSSIBLE "SCAR MANAGEMENT TREATMENT" NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTION PATCH SMART IONTOPHORESIS SYSTEM IONTOPHORESIS DEVICE EGJ EMPI 199488-001 72457

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention