BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX® LANCET DEVICE

    MDR report key: 1893454 · Received November 8, 2010

    Report

    Report Number
    1823260-2010-06633
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    September 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS LANCET PROTRUDES BEYOND THE END CAP OF THE SOFTCLIX DEVICE. NO ACCIDENTAL NEEDLE STICK OCCURRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT ADJUSTABLE GASTRIC BAND, THE PORT FLIPPED. THIS WAS DETECTED BY X-RAY. THE PORT WAS REPLACED ON (B)(6) 2010. IT HAS NOT BEEN DETERMINED. WHEN THE PORT FLIPPED. IT FLIPPED SOMETIME BETWEEN THE FILL ON (B)(6) 2010. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX® LANCET DEVICE LANCET DEVICE FMK ROCHE DIAGNOSTICS BAT008

    Patients

    Seq Age Sex Outcome Treatment
    1