BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 3902908 · Received February 24, 2014

    Report

    Report Number
    2085033-2014-00535
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    January 17, 2014
    Report Date
    February 14, 2014
    Manufacturer
    TENEX HEALTH
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/20/2014 RGA COORDINATOR CALLED REP(B)(4) REQUESTING A VALID LOT NUMBER. ON 02/13/2014 RGA COORD EMAILED (B)(4) TO F/U ON PENDING RETURN.

    Description of Event or Problem · 1

    STAFF SAID THERE WAS A HOLE IN THE SIDE OF THE TUBING NEXT TO THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114243 TX1 TISSUE REMOVAL SYSTEM - MICROTIP ULTRASONIC SURGICAL ASPIRATOR LFL TENEX HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1