BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIS QUATRO SENSOR

    MDR report key: 4933132 · Received July 22, 2015

    Report

    Report Number
    2936999-2015-00645
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    April 10, 2015
    Report Date
    June 29, 2015
    Manufacturer
    CELESTICA ELECTRONICS (S) PTE LTD
    Product Code
    GXY
    PMA / PMN Number
    K093183
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/SERIAL NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THEREFORE, A MANUFACTURING DATE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CORRECT APPLICATION OF A SENSOR ATTRIBUTED TO AN ISSUE WITH A PATIENT'S EYE. IMMEDIATELY AFTER A TEN HOUR PROCEDURE, IT WAS OBSERVED THAT THE PATIENT'S LEFT EYE WAS SWELLING. THREE DAYS LATER THE PATIENT EXPERIENCED A LOSS OF LIGHT REFLEX, PUPIL DILATION, EDEMA OF THE SKIN, AND PTOSIS IN THE LEFT EYE. EYE DROPS WERE APPLIED AND OBSERVATION CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475809 BIS QUATRO SENSOR ELECTRODE SENSOR GXY CELESTICA ELECTRONICS (S) PTE LTD 186-0106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention