BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET, LEG HOLDER

    MDR report key: 3874068 · Received May 28, 2014

    Report

    Report Number
    8010652-2014-00011
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    December 17, 2013
    Report Date
    May 2, 2014
    Manufacturer
    MAQUET GMBH
    Product Code
    FWZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ITS INVESTIGATION MAQUET LEARNED THAT THE PADDING WHICH IS TO BE PLACED ONTO THE TABLE ACCESSORY PRIOR TO USE, WAS NOT PRESENT DURING THIS PROCEDURE. WITHOUT THE PADDING IN PLACE, THE LEG HOLDER WOULD NOT HAVE SUFFICIENT SUPPORT FOR THIS PT'S LARGE CALF CIRCUMFERENCE. IF THE CALF WAS NOT SUPPORTED FOR AN EXTENDED PERIOD, HIGH INNER PRESSURE TO THE LOWER LEG CAN RESULT IN THE INJURY REPORTED. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PT'S LEG WAS SUPPORTED ON A LEG HOLDER (B)(4) DURING A LAPAROSCOPIC TUMORECTOMY. THE PT WAS DIAGNOSED WITH COMPARTMENT SYNDROME AFTER THE PROCEDURE DUE TO THE COMPRESSED SOLEUS MUSCLE. THIS LED TO PROLONGED HOSPITALIZATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314212 MAQUET, LEG HOLDER ACCESSORIES, OPERATING-ROOM, TABLE FWZ MAQUET GMBH 1005.86B0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization