BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHODONTIC SPRING RETAINER

    MDR report key: 7697801 · Received July 17, 2018

    Report

    Report Number
    MW5078470
    Event Type
    Injury
    Date Received
    July 17, 2018
    Date of Event
    July 8, 2018
    Report Date
    July 13, 2018
    Manufacturer
    UNK
    Product Code
    NSR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT ASPIRATED A REMOVABLE ORTHODONTIC TOOTH RETAINER, COMMONLY KNOWN AS A "SPRING" RETAINER. THE APPLIANCE SEATS ON THE ANTERIOR TEETH FROM CANINE TO CANINE. IT IS COMPOSED OF A WIRE FRAMEWORK WITH ACRYLIC ON THE LINGUAL AND LABIAL ASPECTS. THE PATIENT WAS RIDING IN THE CAR, HE ATTEMPTED TO SEAT THE RETAINER AND ASPIRATED IT. THIS WAS NOTICED IMMEDIATELY BY PARENT, WHO TRANSPORTED THE PATIENT TO THE LOCAL HOSPITAL. IT WAS DETERMINED THAT THE OBSTRUCTION WAS POTENTIALLY LIFE-THREATENING AND THAT THE PATIENT WOULD NEED INTERVENTION AT THE LOCAL CHILDREN'S HOSPITAL. HELICOPTER TRANSPORT WAS NOT AVAILABLE, SO AMBULANCE TRANSPORT WAS USED. THANKFULLY, TRANSPORT WAS UNEVENTFUL. I DO NOT HAVE ACCESS TO THE MEDICAL REPORTS, BUT HAVE BEEN INFORMED THAT THE RETAINER WAS RETRIEVED FROM ONE OF THE BRONCHI UNDER GENERAL ANESTHESIA. THE PATIENT WAS SENT HOME, IS DOING WELL AT THIS TIME. HE REPORTS MINOR UPPER AIRWAY ABRASION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538119 ORTHODONTIC SPRING RETAINER PROSTHESIS ORTHODONTIC NSR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R