BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M UNITEK NITINOL CL OFIII OVOID L014

    MDR report key: 6187909 · Received December 19, 2016

    Report

    Report Number
    2020467-2016-00005
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    October 8, 2016
    Report Date
    November 22, 2016
    Manufacturer
    3M UNITEK CORPORAION
    Product Code
    DZC
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON NOVEMBER 22, 2016, 3M WAS NOTIFIED BY A DENTAL OFFICE IN (B)(6) THAT A (B)(6) FEMALE PATIENT HAD SWALLOWED A BROKEN PIECE OF A 3M UNITEK NITINOL CLASSIC ARCHWIRE ON (B)(6) 2016. THE ORTHODONTIC WIRE WAS PLACED IN (B)(6) 2016. THE WIRE WAS EXCRETED IN THE PATIENTS STOOL WITHOUT INCIDENT. WHILE NO INJURY OCCURRED, THIS EVENT IS BEING REPORTED BECAUSE OF THE POTENTIAL FOR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835694 3M UNITEK NITINOL CL OFIII OVOID L014 ORTHODONTIC WIRE DZC 3M UNITEK CORPORAION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other