CARRIERE SLX

Additional Manufacturer Narrative

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

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.