BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEN MEDICAL SYSTEMS VACU-GEL PAD

    MDR report key: 644839 · Received October 14, 2005

    Report

    Report Number
    1221538-2005-00008
    Event Type
    Injury
    Date Received
    October 14, 2005
    Date of Event
    September 16, 2005
    Report Date
    September 16, 2005
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE OR STAFF PLACED THE VACU-GEL PAD ON THE SURGICAL BED AND PLACED A SHEET OVER THE PAD PER THE HOSPITAL PROTOCOL. AS THEY ATTEMPTED TO TRANSFER THE PT FROM THE GURNEY TO THE SURGICAL BED THE SHEET AND THE PT SLID OFF THE VACU-GEL PAD. THE NURSE ON THE OPPOSITE SIDE OF THE SURGICAL BED PREVENTED THE PT FROM FALLING TO THE FLOOR. THERE WAS NO ADVERSE IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS VACU-GEL PAD SURGICAL TABLE ACCESSORY FMP ALLEN MEDICAL SYSTEMS H-008-00-201-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention