BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE GROUNDING PAD W/OUT CABLE

    MDR report key: 8730591 · Received June 25, 2019

    Report

    Report Number
    2182269-2019-00085
    Event Type
    Injury
    Date Received
    June 25, 2019
    Date of Event
    June 5, 2019
    Report Date
    October 17, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    GXD
    UDI-DI
    05415067028914
    PMA / PMN Number
    K111576
    Removal / Correction Number
    FA-Q419-NM_EP-1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DISPOSABLE GROUNDING PAD W/OUT CABLE WAS RETURNED FOR INVESTIGATION. A CLEAR FILM WAS NOTED ON THE SURFACE OF THE GROUNDING PAD. FURTHER INVESTIGATION REVEALED THE GROUNDING PAD WAS ASSEMBLED WITH THE CLEAR FILM ON THE INSIDE LAYER OF THE BLUE LINER.

    Description of Event or Problem · 1

    FOLLOWING A 4-LEVEL UNILATERAL LUMBAR ABLATION PROCEDURE, A PATIENT BURN WAS NOTED AFTER REMOVING THE GROUNDING PAD. THE GROUNDING PAD HAD LEFT A CLEAR FILM ON THE PATIENT FOLLOWING REMOVAL AND A BLISTER WAS NOTED ON THE SKIN UNDER THE LEFT FLANK. THE PATIENTS SKIN WAS NOT PREPPED BEFORE PLACING THE GROUNDING PAD. NO TREATMENT WAS NEEDED TO TREAT THE BURN AND THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524471 DISPOSABLE GROUNDING PAD W/OUT CABLE PROBE, RADIOFREQUENCY LESION GXD ST. JUDE MEDICAL, INC. RF-DGP-L 810319005 05415067028914

    Patients

    Seq Age Sex Outcome Treatment
    1 Other