BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIS QUATRO SENSOR

    MDR report key: 5029190 · Received August 25, 2015

    Report

    Report Number
    2936999-2015-00736
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 3, 2015
    Manufacturer
    CELESTICA (VENDOR)
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLASTIC MATTER CAME OUT FROM NEAR THE FIRST ELECTRODE AND IT CUT AROUND THE PATIENT'S GLABELLA AND NEEDED HEMOSTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561198 BIS QUATRO SENSOR ELECTRODE SENSOR GXY CELESTICA (VENDOR) 186-0106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention