BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EGR SYSTEM (STERILE)

    MDR report key: 2842144 · Received November 13, 2012

    Report

    Report Number
    3004608878-2012-00213
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    November 13, 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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER NOTED: THE DOCTOR STATED THE PATIENT HAD AN EGR PROCEDURE ON 02/04/2012 AND ANOTHER EGR PROCEDURE ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT REPORTED "DISCOMFORT IN THE CALF REGION." THE DOCTOR BELIEVED THIS WAS NEURITIS AND PROVIDED THE PATIENT A CORTISONE INJECTION WHICH "RELIEVED THE PATIENT'S DISCOMFORT." THERE WERE NO ADDITIONAL DOCUMENTED PROBLEMS AFTER THE PROCEDURE ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention