BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAC-PAC

    MDR report key: 645086 · Received September 20, 2004

    Report

    Report Number
    645086
    Event Type
    Other
    Date Received
    September 20, 2004
    Date of Event
    September 16, 2004
    Report Date
    September 20, 2004
    Manufacturer
    OLYMPIC MEDICAL CORP.
    Product Code
    CCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A BEAN BAG DEVICE FOR POSITIONING IN THE OPERATING ROOM. THE BEAN BAG LEAKED OR HAD A HOLE IN IT WHICH CAUSED THE DEVICE TO FAIL, CAUSING HYPEREXTENSION OF THE PATIENT'S NECK AND REQUIRING RE-INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAC-PAC SURGICAL POSITIONING DEVICE CCX OLYMPIC MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR