BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 14596797 · Received June 3, 2022

    Report

    Report Number
    2936999-2022-00498
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 3, 2022
    Manufacturer
    CELESTICA ELECTRONICS S PTE LTD
    Product Code
    GXY
    UDI-DI
    20884521134307
    PMA / PMN Number
    K093183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, POST-OPERATIVELY,  THE PATIENT FELT DISCOMFORT, TINGLING AND NUMBNESS IN THE FOREHEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587765 BIS ELECTRODE, CUTANEOUS GXY CELESTICA ELECTRONICS S PTE LTD 186-0106 20884521134307

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown