BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE 1884004HR TRICUT 5PK M4 4MM ROTATA

    MDR report key: 3233366 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11948
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BLADE BROKE DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333635 BLADE 1884004HR TRICUT 5PK M4 4MM ROTATA BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1884004HR H8762278

    Patients

    Seq Age Sex Outcome Treatment
    1