BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUAMANTYS UNKNOWN DEVICE

    MDR report key: 5103475 · Received September 25, 2015

    Report

    Report Number
    1226420-2015-00158
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 28, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER PATIENT CODES : (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    POST-SURGERY WHILE REMOVING THE MONITORING NEEDLES, THE CUSTOMER REPORTED THAT THE PATIENT HAD REDNESS (A SLIGHT BURN) ON THEIR SKIN. THE CUSTOMER IS NOT SURE AS TO THE CAUSE OF THE REDNESS, THEREFORE THEY ARE REPORTING ALL EQUIPMENT UTILIZED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634512 AQUAMANTYS UNKNOWN DEVICE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK AQM DEV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1