BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLEN HUG-U-VAC STEEP TREND POSITIONER

    MDR report key: 2035822 · Received March 23, 2011

    Report

    Report Number
    1221538-2011-00007
    Event Type
    Other
    Date Received
    March 23, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 25, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHARGE NURSE STATED THAT THE STAFF USED SHOULDER POSITIONERS ON THE TABLE BENEATH THE HUG-U-VAC, AS DIRECTED IN THE INSTRUCTIONS FOR USE, IN THE TRENDELENBURG CASE BUT THAT THE SUPPORTS HAD NO DIRECT CONTACT WITH THE PATIENT'S SHOULDER AT ANY TIME. THE HOSPITAL REPORTED USING PINK FOAM PADDING ALONG THE PATIENT SHOULDERS, WHICH IS NOT INDICATED IN THE INSTRUCTIONS FOR USE FOR THIS PRODUCT. IT IS UNCLEAR IF THIS WAS A CONTRIBUTING FACTOR. VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED UNIT BY AN ENGINEER REVEALED IT WAS FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    FOLLOWING A TRENDELENBURG POSITIONING CASE IN WHICH THE ALLEN HUG-U-VAC STEEP TREND POSITIONER WAS USED, A CUSTOMER CONTACTED THE ALLEN REP POST-OPERATIVELY TO REPORT THE PATIENT WAS EXPERIENCING BI-LATERAL NUMBNESS AND TINGLING IN HER HANDS AND FINGERS. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH SOME OF THE NUMBNESS AND TINGLING SENSATION CONDITION PERSISTING. ADDITIONAL TREATMENT AND FOLLOW-UP MAY BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN HUG-U-VAC STEEP TREND POSITIONER HUG-U-VAC POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-60001-A1 AP1 11 87125

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other