BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCDLE DEVICE CONVENIENCE PACK

    MDR report key: 2170083 · Received June 17, 2011

    Report

    Report Number
    2951580-2011-00089
    Event Type
    Other
    Date Received
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    GEI
    PMA / PMN Number
    K001936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNK. SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND THE LOT NUMBER WAS NOT PROVIDED, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. NO CONCLUSION CAN BE MADE.

    Description of Event or Problem · 1

    PER JOURNAL ARTICLE (PERCUTANEOUS COBLATION NUCLEOPLASTY IN PTS WITH CONTAINED LUMBAR DISC PROLAPSE: ONE YEAR F/U IN A PROSPECTIVE CASE SERIES, SINAN T. ET AL, 2011), IT WAS REPORTED THAT IN THE PERI-OPERATIVE PHASE FOLLOWING THE PROCEDURE, THE PT DEVELOPED DISCITIS WHICH WAS TREATED WITH SURGICAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCDLE DEVICE CONVENIENCE PACK ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other