BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROTHERM RF DISPOSABLE GROUNDING PAD

    MDR report key: 2941505 · Received January 31, 2013

    Report

    Report Number
    1226344-2013-00010
    Event Type
    Other
    Date Received
    January 31, 2013
    Date of Event
    July 28, 2011
    Report Date
    January 29, 2013
    Manufacturer
    NEUROTHERM
    Product Code
    GXD
    PMA / PMN Number
    K052878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON (B)(6) 2011 A NEUROTHERM EMPLOYEE REC'D A CALL FROM THE FACILITY REPORTING A PT BURN. THE L-PAD CORD BECAME HOT AND BURNED THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42095 NEUROTHERM RF DISPOSABLE GROUNDING PAD RF DISPOSABEL GROUNDING PAD GXD NEUROTHERM RF-DGP-C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other