The carriere slx 3d brackets are stainless steel, passive, self-ligating orthodontic brackets that directly bond to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition.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 38-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.Due to the fact that prescription and otc medications were given, ortho organizers decided to report this complaint to the fda.
|
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 38-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.
|