BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUNITI WIRE

    MDR report key: 6142518 · Received December 2, 2016

    Report

    Report Number
    2016150-2016-00006
    Event Type
    Injury
    Date Received
    December 2, 2016
    Date of Event
    October 29, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ORMCO CORPORATION
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A PATIENT HAD SWALLOWED A 2CM PIECE OF ARCH WIRE. WIRE HAS BEEN REPLACED AND NO LONG TERM CONSEQUENCES CAN BE FORESEEN.

    Description of Event or Problem · 1

    PATIENT SWALLOWED 2CM OF WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792090 CUNITI WIRE COPPER NITI WIRE DZC ORMCO CORPORATION 16A8A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other