BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NS252 INNERVATOR

    MDR report key: 118214 · Received September 6, 1997

    Report

    Report Number
    9611451-1997-00001
    Event Type
    Injury
    Date Received
    September 6, 1997
    Date of Event
    July 21, 1997
    Report Date
    August 7, 1997
    Manufacturer
    FISHER & PAYKEL ELECTRONICS LTD.
    Product Code
    KOI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 3RD DEGREE BURNS THAT WERE FOUND UNDER THE ELECTRODE PADS THAT WERE CLIPPED WITH ALLIGATOR CLIPS ON THE LEFT FOREARM. THE CLIPS WERE USED TO SECURE THE PNS ELECTRODE SITE. ONE SMALL INSULATED ALLIGATOR CLIP CAME WITH THE PNS AND THE HOSP STAFF ADDED A LARGER UNINSULATED ALLIGATOR CLIP. THERE WERE TWO BURNS, ONE OF 1 CM, THE OTHER WAS 1.5 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NS252 INNERVATOR PERIPHERAL NERVE STIMULATOR KOI FISHER & PAYKEL ELECTRONICS LTD. NS252JWD *

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention