BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYONICS RF SYSTEM

    MDR report key: 2335265 · Received November 10, 2011

    Report

    Report Number
    2951580-2011-00218
    Event Type
    Injury
    Date Received
    November 10, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 13, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K093165
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE PT'S AGE, GENDER AND CONDITION WERE UNSUCCESSFUL. REF MFRS REPORT #: 2951580-2011-00153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ARTHROSCOPIC PROCEDURE, THE PHYSICIAN (B)(6) NOTED A BURN MARK ACROSS THE PT'S CHEST. THE BURN WAS NOT CLASSIFIED AND NO INFO REGARDING THE TYPE OF TREATMENT WAS PROVIDED FOR THE PT'S INJURY. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYONICS RF SYSTEM ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention