BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-T II ARCHWIRE

    MDR report key: 294086 · Received August 31, 2000

    Report

    Report Number
    2020467-2000-00002
    Event Type
    Injury
    Date Received
    August 31, 2000
    Date of Event
    July 31, 2000
    Report Date
    August 18, 2000
    Manufacturer
    3M UNITEK
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT'S PARENT CALLED ORTHODONTIST ON 7/31/2000 FROM HOME STATING THAT PT HAD SWALLOWED A SEG,EMT PF PRTJPDPMTOC ARCJWORE TJAT BRPLE OM TJE [ATOEMT'S MOUTH. PT HAD X-RAY TAKEN WHICH SHOWED THAT THE WIRE SEGMENT WAS LODGED IN THE PATIENT'S ESOPHAGUS IN THE VICINITY OF THE VOCAL CORDS. THE WIRE WAS SURGICALLY REMOVED ON 08/01/2000. ON 08/02/00 THE ORTHODONTIST PLACED A NEW ORTHODONTIC ARCHWIRE IN THE PT MOUTH IN ORDER TO CONTINUE THE ORTHODONTIC TREATMENT. THE PT REPORTED NO ILL EFFECTS OF THE SURGERY WHEN THE ORTHODONTIST RE-EXAMINED THE PT ON 08/23/00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-T II ARCHWIRE ORTHODONTIC ARCHWIRE DZC 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention ORTHODONTIC, BRACKETS, BUCCAL TUBES, AND ADHESIVE.