BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIO. ELEV. 7 1/4" CVD 3MM

    MDR report key: 5035422 · Received August 27, 2015

    Report

    Report Number
    1044475-2015-00320
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 3, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FFO
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE ARE NO APPROPRIATE RESULT AND CONCLUSION CODES. A SAMPLE OF KM46207 LOT D3 WAS RECEIVED FOR EVALUATION. THE KMEDIC PART NUMBER IS NOT ETCHED ON THE DEVICE. THE DEVICE WAS IDENTIFIED BY KEY ATTRIBUTES. A STOCK CHECK WAS OPENED TO VERIFY THE DEVICES IN STOCK. THE REPORTED DEVICE WAS KM46206 WHICH IS 3MM NARROWER AT THE TIP. THE SALES ORDER ALSO REFLECTS A KM46206 WAS SENT TO THE CUSTOMER. THE ROOT CAUSE IS UNKNOWN. THE DEVICE HISTORY REVIEW OF NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS SHOWED NO CONCERNS WITH REFERENCE TO KM46206 OR KM46207. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE TIP OF THE INSTRUMENT BROKE OFF WHILE INSIDE THE PATIENT. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570365 PERIO. ELEV. 7 1/4" CVD 3MM FFO TELEFLEX MEDICAL B13566690336

    Patients

    Seq Age Sex Outcome Treatment
    1