(b)(4).Although we have established that user error caused the injuries to the patients and the patient did not seek treatment from a secondary provider, and all tissues have healthed without permanent damage, kulzer, llc is reporting this out of an abundance of caution, due to the (b)(6) requesting that this be reported and at the request of our global safety officer.
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Incident occured in (b)(6).(b)(6) yo female.Hyposalivation, smoker.Patient medications include lamictal and somac.After treatment with gluma desensitizer powergel, the patient had gingival injuries, headache, skin reaction, burning feeling, swelling/edema.Treating dds applied the product to what appears to be multiple areas.The dds did not use isolation, nor did they rinse the material after application.The product was applied and the patient was allowed to leave the office with the material still on the teeth.Per the office on (b)(6) 2018, the patient did not seek secondary treatment and they had been seen back at the office for a follow up visit and the provider was able to confirm that the injury has completely healed without permanent damage.
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