BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARRIERE SLX

    MDR report key: 17847505 · Received September 29, 2023

    Report

    Report Number
    2081322-2023-00002
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    October 29, 2022
    Report Date
    September 29, 2023
    Manufacturer
    ORTHO ORGANIZERS, INC.
    Product Code
    EJF
    UDI-DI
    00190707019129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CARRIERE SLX METAL BRACKETS ARE A SINGLE-USE, STAINLESS STEEL, SELF-LIGATING ORTHODONTIC BRACKETS. IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 29-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL. THE DOCTOR INDICATED IN THE PATIENT QUESTIONNAIRE THAT IF THE DEVICE MALFUNCTION WERE TO RECUR, IT WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. ALSO, NO DOCTOR OR HOSPITAL VISIT WAS REQUIRED, AND AS INDICATED IN THE QUESTIONNAIRE, THE PATIENT HAS FULLY RECOVERED. DUE TO THE FACT THAT PRESCRIPTION AND OTC MEDICATIONS WERE GIVEN, ORTHO ORGANIZERS DECIDED TO REPORT THIS COMPLAINT TO THE FDA.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE CUSTOMER COMPLAINT FORM THAT BRACKET LR4 HAD SHARP EDGES CAUSING CHEEK IRRITATION, CUTTING THE CHEEK ON THE LOWER RIGHT OF THE PATIENT AND CAUSING LARGE SORES THAT DID NOT HEAL. THE SYMPTOMS BEGAN THE DAY AFTER THE BRACKET WAS PLACED. THE BRACKET NEEDED TO BE REMOVED AND REPLACED WITH A DIFFERENT BRAND. THE 29-YEAR OLD FEMALE PATIENT WAS PRESCRIBED KENALOG IN ORABASE, A TOPICAL STEROID. SHE WAS ALSO ADVISED TO TAKE OTC PAIN MEDICATION SUCH AS IBUPROFEN AND TYLENOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288221 CARRIERE SLX ORTHODONTIC METAL BRACKETS EJF ORTHO ORGANIZERS, INC. 713-387HK-10 00190707019129

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention