BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSS (PRIVATE LABELED BY AARON MEDICAL)

    MDR report key: 648885 · Received December 1, 2005

    Report

    Report Number
    1030322-2005-00002
    Event Type
    Injury
    Date Received
    December 1, 2005
    Date of Event
    October 31, 2005
    Report Date
    November 29, 2005
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN'S OFFICE REPORTED THAT A PATIENT ALMOST BLED TO DEATH DURING A PROCEDURE. OFFICE STAFF REPORTED THAT THE DEVICE, AN ELECTROSURGICAL GENERATOR, STOPPED WORKING AND WAS NOT CAUTERIZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSS (PRIVATE LABELED BY AARON MEDICAL) ELECTROSURGICAL GENERATOR GEI AARON MEDICAL INDUSTRIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *