BEUDAMED
    FDA Adverse Event Injury Summary report: N

    A&E MEDICAL CORPORATION - SUCTION COAGULATOR

    MDR report key: 6786367 · Received August 10, 2017

    Report

    Report Number
    2242056-2017-00004
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    May 23, 2017
    Report Date
    August 10, 2017
    Manufacturer
    A&E MEDICAL CORPORATION
    Product Code
    FEH
    UDI-DI
    10841291104865
    PMA / PMN Number
    K881413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINED UPON SUCTION COAGULATOR DEVICE (050-005, LOT 198C) WAS RETURNED TO A&E MEDICAL FOR INVESTIGATION. THE DEVICE WAS RECEIVED ON 7/24/2017. (REF. (B)(4)) THE DEVICE WAS REVIEWED THROUGH THE CLEAR PLASTIC PACKAGING UPON RECEIPT AND FOUND TO BE SATISFACTORY VISUALLY WITHOUT OPENING THE PACKAGE. THE DEVICE HAS BEEN SENT TO THE STERILIZER AS PART OF THE A&E MEDICAL DECONTAMINATION PROCESS ON 8/3/2017. THE DEVICE HAS NOT RETURNED AS OF THIS PRELIMINARY REPORT. THE DEVICE WILL BE REVIEWED AND ELECTRICALLY TESTED UPON ITS RETURN, ESTIMATED TO BE THE WEEK OF 8/14/2017. A FOLLOW UP REPORT SHALL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED UPON SUCTION COAGULATOR DEVICE (050-005, LOT 198C) WAS RETURNED TO A&E MEDICAL FOR INVESTIGATION. THE DEVICE WAS RECEIVED ON 7/24/2017. (REF. RGA 170717-02) THE DEVICE WAS REVIEWED THROUGH THE CLEAR PLASTIC PACKAGING UPON RECEIPT AND FOUND TO BE SATISFACTORY VISUALLY WITHOUT OPENING THE PACKAGE. THE DEVICE HAS BEEN SENT TO THE STERILIZER AS PART OF THE A&E MEDICAL DECONTAMINATION PROCESS ON 8/3/2017. THE DEVICE HAS NOT RETURNED AS OF THIS PRELIMINARY REPORT. THE DEVICE WILL BE REVIEWED AND ELECTRICALLY TESTED UPON ITS RETURN, ESTIMATED TO BE THE WEEK OF 8/14/2017. A FOLLOW UP REPORT SHALL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. UPON REVIEW OF RETURNED DEVICE AFTER DECONTAMINATION PROCESS IT WAS OBSERVED THE RETURNED DEVICE WAS IN A SEALED POUCH THAT WAS NEVER OPENED. A CALL TO THE COMPLAINANT CONFIRMED THE RETURNED DEVICE WAS NOT THE DEVICE COMPLAINED UPON. THE COMPLAINED UPON DEVICE WAS DISCARDED BY THE USER. THE RETURNED DEVICE WAS FROM THE SAME LOT NUMBER AND THUS A&E MEDICAL INVESTIGATED AND TESTED THE RETURNED DEVICE. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS FOUND TO HAVE LOWER LIP SWELLING, THOUGHT TO BE DUE TO ELECTRICAL BURN FROM SUCTION COAGULATOR. PATIENT WAS TREATED WITH POLYSPORIN AND OBSERVED CLOSELY.

    Description of Event or Problem · 1

    PATIENT WAS FOUND TO HAVE LOWER LIP SWELLING, THOUGHT TO BE DUE TO ELECTRICAL BURN FROM SUCTION COAGULATOR. PATIENT WAS TREATED WITH POLYSPORIN AND OBSERVED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565243 A&E MEDICAL CORPORATION - SUCTION COAGULATOR SUCTION COAGULATOR FEH A&E MEDICAL CORPORATION 050-005 198C 10841291104865

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention