BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGR SYSTEM (STERILE)

    MDR report key: 2842070 · Received November 12, 2012

    Report

    Report Number
    3004608878-2012-00210
    Event Type
    Injury
    Date Received
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    NBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER NOTED: THE DOCTOR STATED 3 DAYS AFTER EGR PROCEDURE (EGR WAS PERFORMED ON (B)(6) 2012) THE PT RETURNED TO THE OFFICE ON (B)(6) 2012 AND "MENTIONED CALF DISCOMFORT." THE DOCTOR BELIEVED THIS WAS NEURITIS AND PROVIDED A CORTISONE INJECTION WHICH GAVE RELIEF TO THE PT'S DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EGR SYSTEM (STERILE) ENDOSCOPIC GASTROC RELEASE NBH INTEGRA LIFESCIENCES CORPORATION OH/USA PA0009

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention