BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMACHROME STANDARD STAINLESS STEEL STRIAGHT ARCH WIRE

    MDR report key: 511933 · Received February 16, 2004

    Report

    Report Number
    2020467-2004-00002
    Event Type
    Injury
    Date Received
    February 16, 2004
    Date of Event
    January 9, 2004
    Report Date
    February 5, 2004
    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 FAMILY MEMBER REPORTED TO ORTHODONTIST THAT A RETAINER WIRE WAS LOOSE IN PATIENT'S MONTH, BUT THAT BEFORE AN APPOINTMENT COULD BE MADE TO SECURE THE RETAINER WIRE, PATIENT SWALLOWED THE WIRE WHICH WAS APPROX ONE AND A HALF INCHES IN LENGTH. SUBSEQUENT X-RAYS SHOWED THAT THE WIRE PASSED THROUGH THE PATIENT'S INTESTINE BUT NOW IS EMBEDDED IN TISSUE BETWEEN THE BLADDER AND THE RECTUM. PATIENT'S PHYSICIAN RECOMMENDS LEAVING THE WIRE ATS ITS CURRENT SITE. PATIENT PLANS TO SEEK A SECOND OPINION AS TO WHETHER OR NOT THE WIRE SHOULD BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMACHROME STANDARD STAINLESS STEEL STRIAGHT ARCH WIRE ORTHODONTIC WIRE DZC 3M UNITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention COMPOSITE BONDING ADHESIVE. THERAPY DATES: 2004.