BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE 7828-13 13MM W/BASKET MOURE

    MDR report key: 3337515 · Received August 29, 2013

    Report

    Report Number
    9680837-2013-00126
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MEDTRONIC XOMED INSTRUMENTATION S.A.S.
    Product Code
    KBJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE (PART#7828-13) WAS EVALUATED AND INDICATED THAT CURETTE WAS BROKEN UPON FIRST USE. (B)(4). NOTE: THIS MDR IS BEING FILED AS A RESULT OF AN INTERNAL REVIEW OF COMPLAINTS FROM MEDTRONIC'S MXI FACILITY IN (B)(4). THIS REVIEW WAS CONDUCTED TO RESOLVE SEVERAL ISSUES DISCOVERED IN THE MXI COMPLAINT HANDLING PROCESS. ISSUES RESOLVED INCLUDE THE MISCLASSIFICATION OF DEVICES RETURNED FOR REPAIR, AS WELL AS GAPS IN REPORTING. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE (PART#: 7828-13) WAS RETURNED TO MXI SERVICE AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424676 CURETTE 7828-13 13MM W/BASKET MOURE KBJ MEDTRONIC XOMED INSTRUMENTATION S.A.S. 7828-13

    Patients

    Seq Age Sex Outcome Treatment
    1