BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROTHERM RF DISPOSABLE GROUNDING PAD

    MDR report key: 2956371 · Received February 7, 2013

    Report

    Report Number
    1226344-2013-00009
    Event Type
    Other
    Date Received
    February 7, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 7, 2013
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEUROTHERM SALES REP REVIEWED THE IFU AND WARNINGS ON PROPER USE WITH THE FACILITY AFTER THE REPORT OF THE BURN. THE IFU STATES, "SELECT A WELL-VASCULARIZED MUSCULAR SITE IN PROXIMITY TO THE PROCEDURE." DOCTOR CONFIRMED TO THE NEUROTHERM SALES REP THAT THE GROUNDING PAD WAS NOT PLACED IN THE IDEAL LOCATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A NEUROTHERM EMPLOYEE RECEIVED A CALL FROM THE FACILITY REPORTING A PT BURN. THE PT WAS DISCHARGED FROM THE FACILITY. DURING A FOLLOW-UP VISIT, THE PT SHOWED THE FACILITY A BURN AT THE SITE WHERE THE GROUNDING PAD WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51987 NEUROTHERM RF DISPOSABLE GROUNDING PAD RF DISPOSABLE GROUNDING PAD GXD NEUROTHERM, INC. RF-DGP-L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other