BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN GENERATOR

    MDR report key: 724046 · Received June 6, 2006

    Report

    Report Number
    1643264-2006-00030
    Event Type
    Other
    Date Received
    June 6, 2006
    Date of Event
    April 3, 2006
    Report Date
    June 5, 2006
    Manufacturer
    SMITH & NEPHEW, INC.- ENDOSCOPY DIV
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED IN BEACH CHAIR POSITION AND PAD WAS PLACED ON THE BONY PROMINENCE OF THE SCAPULA, SAME SIDE AS SURGERY SITE. THE PT SUFFERED A 1ST DEGREE BURN ON SCAPULA FROM THE GROUND PAD. IT WAS REPORTED THAT THE PT WAS OBESE. THE CUSTOMER USED THE VALLEY LAB REM POLY # E7507.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN GENERATOR * HRX SMITH & NEPHEW, INC.- ENDOSCOPY DIV 7209673 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other