BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IONTOPHOR - PM

    MDR report key: 5659 · Received April 5, 1993

    Report

    Report Number
    5659
    Event Type
    Injury
    Date Received
    April 5, 1993
    Date of Event
    March 9, 1993
    Report Date
    March 17, 1993
    Manufacturer
    LIFE-TECH, INC.
    Product Code
    KTB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT. SEEN FOR 1ST TREATMENT FOR IONTOPHORESIS, 2 ELECTRODES WERE PLACED APPROPRIATELY, UPON CONCLUSION OF TREATMENT, ELECTRODES WERE REMOVED & THERE WERE SEVERAL SMALL BLISTERSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IONTOPHOR - PM IONTOPHRESIS KTB LIFE-TECH, INC. 6111PM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention