BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CREATURES OF THE SEA

    MDR report key: 20782233 · Received November 26, 2024

    Report

    Report Number
    20782233
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    August 20, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ORTHO TECHNOLOGY, INC.
    Product Code
    ECI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IN THE LAST 8 DAYS, I HAVE ADMITTED 3 PATIENTS INTO THE PACU FOLLOWING GENIOPLASTY SURGERY. IN EACH CASE THE PATIENT HAD RUBBER BANDS APPLIED TO THE WIRE BANDS ON THEIR TEETH TO PROVIDE STABILITY AND TO PREVENT THE OPENING OF THE MOUTH. IN EACH SITUATION THE RUBBER BANDS HAVE BROKEN WITHIN AN HOUR OF PATIENT¿S ARRIVAL IN PACU. IN THE FIRST PATIENT, 6 RUBBER BANDS BROKE. THE SECOND PATIENT HAD 2 RUBBER BANDS BREAK. THE THIRD PATIENT HAD 1 RUBBER BAND BREAK. I HAD TO REMOVE THE BROKEN BANDS WITH FORCEPS. IN EACH SITUATION THE PATIENT WAS BEING COMPLIANT AND NOT DOING ANYTHING TO CAUSE THE BANDS TO BREAK. NEW BANDS HAD TO BE APPLIED BY OMS (ORAL MAXILLOFACIAL SURGERY) RESIDENT WHICH CAUSED EXTRA DISCOMFORT TO THE PATIENT. I NOTIFIED THE SAFETY COACH AT THE OR DESK OF EACH SITUATION TO SEE IF THE RUBBER BANDS MAY BE OUTDATED. THE PACKAGES FOR THE BANDS WERE CHECKED AND NOT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575814 CREATURES OF THE SEA BAND, ELASTIC, ORTHODONTIC ECI ORTHO TECHNOLOGY, INC. 500-303LF 20210820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose