BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET LEG HOLDER

    MDR report key: 8000366 · Received October 24, 2018

    Report

    Report Number
    8010652-2018-00025
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    September 25, 2018
    Report Date
    January 23, 2019
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED. 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).

    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. (B)(4), CONTACT PERSON: (B)(6). THE CUSTOMER REPORTED THAT A COMPARTMENT SYNDROME OCCURRED DURING SURGERY WITH A GETINGE-MAQUET PRODUCT. THE CLINIC CONFIRMED THAT THERE WAS NO MALFUNCTION OF THE USED PRODUCT. A COMPARTMENT SYNDROME CAN BE CAUSED DUE TO DIFFERENT INFLUENCES ( PATIENT POSITION, OPERATING TIME, LITHOTOMY POSITION, ANKLE ABOVE HEART LEVEL, P STRONG LOWER LEG AND / OR HIGH BMI, INTRAOPERATIVE COMPRESSION OF THE LARGE VESSELS, A HISTORY OF CARDIOVASCULAR ISSUES). SINCE NO PRODUCT MALFUNCTION WAS REPORTED, WE ASSUME THAT IN THIS CASE SEVERAL UNFAVORABLE FACTORS CAME TOGETHER AND THUS LED TO THE DESCRIBED INJURY. THE CLINIC REPORTED THAT AFTER ONE MONTH OF HOSPITALIZATION THE PATIENT LEFT THE HOSPITAL. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE PATIENT'S LEG WAS SUPPORTED ON A LEG HOLDER 100586B0 DURING A SURGICAL PROCEDURE. THE PATIENT WAS DIAGNOSED WITH COMPARTMENT SYNDROME AFTER THE PROCEDURE. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839890 MAQUET LEG HOLDER TABLE, OPERATING-ROOM, AC-POWERED FQO 100586B0

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other