BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENT PLASMA WAND

    MDR report key: 2093603 · Received April 15, 2011

    Report

    Report Number
    2951580-2011-00064
    Event Type
    Other
    Date Received
    April 15, 2011
    Date of Event
    January 1, 2006
    Report Date
    April 15, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K070374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNK. PER JOURNAL ARTICLE, THE PROCEDURE WAS PERFORMED BETWEEN JANUARY 2006 AND DECEMBER 2007. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND A LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    PER JOURNAL ARTICLE, IT WAS REPORTED A PEDIATRIC PT HAD COMPLICATIONS FOLLOWING A TONSILLECTOMY PROCEDURE INVOLVING SEVERE PAIN REQUIRING HOSPITALIZATION ON POSTOPERATIVE DAY 2 FOR 3 DAYS. THE PT WAS TREATED WITH INTRAVENOUS HYDRATION, PENICILLIN, AND MORPHINE HYDROCHLORIDE. THE PROCEDURE WAS PERFORMED BETWEEN JANUARY 2006 AND DECEMBER 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENT PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other