BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 13094564 · Received December 28, 2021

    Report

    Report Number
    2936999-2021-01241
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Report Date
    December 28, 2021
    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, REDNESS WAS NOT OBSERVED IMMEDIATELY AFTER THE ELECTRODE WAS PEELED FROM THE PATIENT'S HEAD, BUT IT WAS OBSERVED IN THE ATTACHED SITE 2 DAYS LATER. SINCE THE 5TH DAY, IT BECAME THINNER AND IT DISAPPEARED ON THE 10TH DAY, THE TIME OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1992263 BIS ELECTRODE, CUTANEOUS GXY CELESTICA ELECTRONICS S PTE LTD 186-0106 20884521134307

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Female