BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED DIAMOND DCR BUR, 2.5MM, HI-SPD 3/BX

    MDR report key: 3811917 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09011
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. DEVICE RECEIVED IN (B)(6) ON (B)(6) 2014, AND FORWARDED TO MEDTRONIC XOMED, INC., ON (B)(6) 2014. IT HAS NOT BEEN RECEIVED YET FOR EVALUATION. (B)(4). PRODUCT EVALUATION: NO ANALYSIS RESULTS AVAILABLE. DEVICE RECEIVED IN CHINA ON APRIL 28, 2014, AND FORWARDED TO MEDTRONIC XOMED, INC., ON (B)(6) 2014; NOT RECEIVED YET FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    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 THE ¿HEAD CONNECTED TO THE HANDLE TURN OFF AFTER 2 LAPS.¿ THERE WAS NO PATIENT IMPACT. THIS INDICATES THAT THE PRODUCT WAS BROKEN AFTER IT WAS CONNECTED TO THE HANDLE AND PUT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290159 CURVED DIAMOND DCR BUR, 2.5MM, HI-SPD 3/BX BUR, EAR, NOSE AND THROAT EQJ MDT PUERTO RICO OPERATIONS CO 1882569HS H8916411

    Patients

    Seq Age Sex Outcome Treatment
    1