BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOMEDICAL NEOMAGIC

    MDR report key: 1698942 · Received May 21, 2010

    Report

    Report Number
    2925153-2010-00006
    Event Type
    Other
    Date Received
    May 21, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 21, 2010
    Manufacturer
    NEOMEDICAL
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ASSESSED AND DETERMINED TO BE A MDR REPORT BASED ON OUR MDR REPORTING CRITERIA. THE INFO PROVIDED WITH THE REPORT IS SKETCHY. ADD'L INFO HAS BEEN REQUESTED BUT HAS NOT BEEN REC'D. AN EXAMINATION OF THE DEVICE HAS NOT BEEN CARRIED OUT AS THE USED ITEM WAS NOT RETURNED TO (B)(4).

    Description of Event or Problem · 1

    BASED ON THE REPORT INFO, SUBMITTED TO (B)(4) ON (B)(6) 2010, A PICC BROKE DURING SURGERY ON (B)(6) 2010. THE PRODUCT IS (B)(4). NO OTHER INFO HAS BEEN MADE AVAILABLE. THE USED PRODUCT / SAMPLE WAS NOT RETURNED TO (B)(4). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOMEDICAL NEOMAGIC NEOMAGIC PICC DQY NEOMEDICAL 1961-1630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention