BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONE HEADREST

    MDR report key: 8331826 · Received February 12, 2019

    Report

    Report Number
    8010652-2019-00005
    Event Type
    Injury
    Date Received
    February 12, 2019
    Date of Event
    February 7, 2019
    Report Date
    September 25, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    LWG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUSLY SELECTED PRODUCT CODE JZR WAS CORRECTED WITH LWG.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). PRESSURE ULCERS CAN BE CAUSED DUE TO DIFFERENT INFLUENCES (PREEXISTING MEDICAL CONDITIONS, PATIENT AGE, DURATION OF THE POSITION, UNFAVORABLE POSITIONING OF THE PATIENT, ETC.). NO DAMAGE OR MALFUNCTION OF THE USED GEL PAD WAS REPORTED. IN THE INSTRUCTIONS FOR USE (IFU) THE USER IS WARNED REGARDING THE RISKS RELATED TO IMPROPER PATIENT POSITIONIN. QUOT IFU: "WARNING! RISK OF INJURY! IMPROPER PATIENT POSITIONING MAY CAUSE HEALTH DAMAGE (E. G. DECUBITUS). POSITION THE PATIENT CORRECTLY AND KEEP UNDER CONSTANT OBSERVATION." NO MALFUNCTION OF THE GETINGE - MAQUET DEVICE WAS REPORTED. WE ASSUME THAT IN THIS CASE SEVERAL UNFAVORABLE FACTORS CAME TOGETHER AND THUS LED TO THE DESCRIBED INJURY. SINCE AN INJURY WAS REPORTED TO GETINGE- MAQUE WE DECIDED TO REPORT TIS CASE TO THE COMPETENT AUTHORITEIS. GETINGE-MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # 2019-62403.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEVELOPED DECUBITUS ON THE CHIN WHILE A (B)(4) - MAQUET GEL PAD WAS IN USE. THE PATIENT WAS UNDER ANAESTHESIA AND IN A PRONE POSITION. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125528 PRONE HEADREST SURGICAL TABLE CUSHION LWG HOLGER ULLRICH 40061900

    Patients

    Seq Age Sex Outcome Treatment
    1 Other