BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFRANCE® INSTRUMENT

    MDR report key: 4673995 · Received April 9, 2015

    Report

    Report Number
    9680837-2015-00031
    Event Type
    Malfunction
    Date Received
    April 9, 2015
    Date of Event
    March 17, 2015
    Report Date
    March 17, 2015
    Manufacturer
    XOMED MICROFRANCE MFG
    Product Code
    JYQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT ; MATERIAL FRAGMENTATION. THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, AN ANALYSIS CANNOT BE PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    CORRECTION. CONCLUSION: DEVICE NOT RETURNED.

    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 INSTRUMENT BROKE AFTER A FEW USES. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE WITH NO RESPONSE RECEIVED. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235653 MICROFRANCE® INSTRUMENT LOOP, WIRE JYQ XOMED MICROFRANCE MFG 7718 130902

    Patients

    Seq Age Sex Outcome Treatment
    1