BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 11691437 · Received April 19, 2021

    Report

    Report Number
    2936999-2021-00364
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 19, 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
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT EXPERIENCED SKIN IRRITATION WITH THE DEVICE. THE DEVICE ALSO LOST ITS ADHESION DUE TO EXCESSIVE SWEATING OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581570 BIS ELECTRODE, CUTANEOUS GXY CELESTICA ELECTRONICS S PTE LTD 186-0106 20884521134307

    Patients

    Seq Age Sex Outcome Treatment
    1