BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE

    MDR report key: 5008532 · Received August 15, 2015

    Report

    Report Number
    2418500-2015-00003
    Event Type
    Injury
    Date Received
    August 15, 2015
    Report Date
    July 17, 2015
    Manufacturer
    GAC INTERNATIONAL
    Product Code
    ECN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. HOWEVER, IF THIS MALFUNCTION RECURRED, IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. THIS EVENT, THEREFORE, IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW.

    Description of Event or Problem · 1

    IN THIS EVENT AN ATTORNEY REPORTED THAT AN ADULT ORTHODONTIC PATIENT CLAIMS TO HAVE SWALLOWED AN ARCHWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540973 STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE WIRE, ORTHODONTIC ECN GAC INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other