BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARTHROWAND (MODEL UNKNOWN)

    MDR report key: 357537 · Received October 19, 2001

    Report

    Report Number
    2951580-2001-00019
    Event Type
    Other
    Date Received
    October 19, 2001
    Date of Event
    February 21, 2000
    Report Date
    October 19, 2001
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON 08/2001, IT WAS REPORTED TO ARTHROCARE CORPORATION THAT A BURN WAS NOTICED ON A PATIENT'S RIGHT KNEE FOLLOWING A LATERAL RELEASE PROCEDURE USING AN ARTHROWAND (MODEL UNKNOWN). ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND LATERAL RELEASE TO THE RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47150 ARTHROWAND (MODEL UNKNOWN) ELECTROSURGICAL DEVICE GEI ARTHROCARE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other