BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERELASTIC REGULAR FORCE NITI ARCHWIRES

    MDR report key: 3553372 · Received December 20, 2013

    Report

    Report Number
    2939494-2013-00002
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    December 9, 2013
    Report Date
    December 20, 2013
    Manufacturer
    HIGHLAND METALS, INC.
    Product Code
    DZC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE CUSTOMERS IN THE USA KNOWN TO HAVE RECEIVED (B)(4) LOT 41684 ((B)(4) PACKS IN TOTAL SENT). THESE CUSTOMERS WERE SENT A FIELD SAFETY NOTICE ON 2013-12-13 VIA FAX OR EMAIL INFORMING THEM TO CHECK THE PRODUCT RECEIVED TO DETERMINE IF IT CONTAINS THE WRONG PRODUCT. THE DOCTOR HAS BEEN GIVEN THE OPTION TO KEEP THE PRODUCT, OR RETURN TO HIGHLAND METALS, INC FOR A REFUND. DISTRIBUTORS MUST CONTACT EACH OF THEIR CUSTOMERS THAT MAY HAVE RECEIVED THE PRODUCT TO INFORM THEM OF THE INCIDENT AND FOR THEM TO TAKE THE SAME ACTION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE USA RETURNED A MISLABELED PACKAGE OF NITI ORTHODONTIC WIRES (REFER REPORT 2939494-2013-00001). DURING INVESTIGATION INTO THAT INCIDENT RETENTION SAMPLES OF PRODUCT PACKED DURING SAME PERIOD WERE CHECKED. THE SAMPLE FOR PRODUCT (B)(4), LOT 41684, WAS FOUND TO CONTAIN .016" NATURAL LOWER FORM ORTHODONTIC ARCHWIRES, NOT THE .016" NATURAL UPPER FORM ARCHWIRE AS STATED ON THE LABEL. THE ARCHWIRE IS MARKED WITH AN INK MIDLINE - THE MIDLINE SHOULD BE A BLACK COLOR USED FOR UPPER ARCHWIRES BUT IN THIS CASE WERE RED COLOR FOR LOWER ARCHWIRES. THIS IS EASILY IDENTIFIABLE BY THE ASSISTANT AND DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669356 SUPERELASTIC REGULAR FORCE NITI ARCHWIRES WIRE, ORTHODONTIC DZC HIGHLAND METALS, INC. .016 NATURAL UPPER 41684

    Patients

    Seq Age Sex Outcome Treatment
    1