BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUG-U-VAC STEEP TREND POSITIONER

    MDR report key: 5032471 · Received August 26, 2015

    Report

    Report Number
    1221538-2015-00002
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 17, 2015
    Report Date
    August 6, 2015
    Manufacturer
    ALLEN MEDICAL SYSTEMS, INC.
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGERY WAS BEING PERFORMED ON A MAQUET TABLE. FOLLOWING THE INCIDENT THE MAQUET SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND NO PROBLEMS. HE NOTED THAT THERE WERE A SET OF ALLEN BRAND STIRRUPS ATTACHED TO THE TABLE. PHOTOGRAPHS OF THE STIRRUPS WERE SENT TO ALLEN. IT IS NOTED THAT ONE OF THE STIRRUPS IS BENT. FOLLOWING THE INITIAL PROCEDURE, THE PATIENT, STILL IN LITHOTOMY POSITION, WAS PLACED IN REVERSE TRENDELENBURG USING THE HUG U VAC AND STIRRUPS ON THE TABLE TO SECURE HER TO THE TABLE. WITHOUT ADDING ANY OTHER SUPPORTS AND STILL IN LITHOTOMY POSITION, THE PATIENT¿S WEIGHT CAME DOWN ON THE STIRRUPS AND LED TO THE FEMUR FRACTURE. THE ALLEN HUG-U-VAC STEEP TREND POSITIONERS SAFELY HOLD PATIENTS IN THE STEEP TRENDELENBURG POSITION AND ARE NOT INDICATED FOR USE WHEN THE PATIENT IS PLACED IN REVERSE TRENDELENBURG. NO MALFUNCTION / NO RETURN.

    Description of Event or Problem · 1

    THE PATIENT WAS POSITIONED IN TRENDELENBURG AND IN LITHOTOMY POSITION USING A HUG-U-VAC AND STIRRUPS FOR THE INITIAL HYSTEROSCOPY. AFTER THAT PROCEDURE, SHE WAS PLACED IN REVERSE TRENDELENBURG WITHOUT ADDING ANY OTHER SUPPORTS AND STILL IN LITHOTOMY POSITION. THE HUG-U-VAC IS NOT INDICATED FOR THIS POSITIONING. THE PATIENT SLID DOWN THE TABLE CAUSING A FEMORAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563614 HUG-U-VAC STEEP TREND POSITIONER STEEP TREND POSITIONER FWZ ALLEN MEDICAL SYSTEMS, INC. A-60001-A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ALLEN PAL STIRRUPS - SN (B)(4)