BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VULCAN GENERATOR

    MDR report key: 2243977 · Received September 7, 2011

    Report

    Report Number
    MW5022166
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 29, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF REMOVING STERILE DRAPES AFTER PROCEDURE IT WAS NOTED THAT THE GROUNDING PAD WAS COMING OFF WITH THE DRAPES. THE REST OF THE PAD WAS REMOVED AND THE SKIN AT THE APPLICATION SITE WAS NOTED TO BE REDDENED. PATIENT QUESTIONED NURSING STAFF REGARDING THE SAME AND SMALL FLAT REDDENED AREAS WERE NOTED AND ALSO A QUARTER SIZE FLUID FILLED BLISTER. DISCHARGED AS PLANNED. REMOVED FROM SERVICE AND SENT TO CLINICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN GENERATOR GEI SMITH & NEPHEW VG5716

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention