BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BIS PRODUCT

    MDR report key: 3893977 · Received June 9, 2014

    Report

    Report Number
    2936999-2014-00510
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 13, 2014
    Manufacturer
    CELESTICA ELECTRONICS
    Product Code
    GXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR EVALUATION. THE EXACT DEVICE BRAND NAME, CATALOG NUMBER, LOT NUMBER, AND EXPIRATION DATE ARE UNKNOWN; THEREFORE, THE 510(K) NUMBER AND DEVICE MANUFACTURE DATE ARE UNKNOWN. A COVIDIEN ACCOUNT EXECUTIVE VISITED THE CUSTOMER AND DISCUSSED PRONE POSITIONING AND PROLONGED SURGERIES WITH THE REPORTING PHYSICIAN. THE BIS SENSOR INSTRUCTIONS FOR USE (IFU) CONTAINS A CAUTION STATING: IF SKIN RASH OR OTHER UNUSUAL SYMPTOM DEVELOPS, STOP USE AND REMOVE. LIMITED TO SHORT-TERM USE (MAXIMUM OF 24 HOURS). THE IFU ALSO CONTAINS THE FOLLOWING-NOTE: UPON REMOVAL, SLIGHT REDNESS OF SKIN MAY BE SEEN AND TYPICALLY RESOLVES WITHIN A SHORT PERIOD OF TIME. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION FROM A CUSTOMER IN THE USA STATING THAT A PEDIATRIC PATIENT HAD "MARKS ON THEIR FOREHEAD FROM HAVING A BIS SENSOR PLACED THERE." A PHOTOGRAPH OF THE PATIENT'S FOREHEAD SHOWS TWO SMALL ROUND AREAS WITH RED BROKEN SKIN. THE REPORTING PHYSICIAN STATED THAT THE SKIN ISSUE WAS SEEN IMMEDIATELY AFTER THE SURGERY CASE, AND HE ASSUMES IT WAS TREATED WITH OINTMENTS BUT WAS NOT CERTAIN IF THE TREATMENT REQUIRED A PRESCRIPTION MEDICATION. HE ALSO NOTED THAT THE SKIN WOUND CARE TEAM WAS NOTIFIED TO TREAT THE PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR A BACK CONDITION AND WAS IN THE PRONE POSITION WITH HEAD ON A POSITIONING T-SHAPED PILLOW FOR A "PROLONGED PERIOD." THE EXACT NUMBER OF HOURS WAS NOT REPORTED. THE EXACT BIS PRODUCT NAME AND LOT NUMBER WAS UNKNOWN BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336591 UNSPECIFIED BIS PRODUCT ELECTRODE SENSOR GXY CELESTICA ELECTRONICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROCARE T-SHAPED PILLOW