The patient reported that she experienced an allergic reaction after using the ema appliance.After using the appliance for a few days after delivery, the patient developed swelling and ulcers where appliance contacted the inner cheek region, buccal and lingual tissue and lips.
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The patient reported that she experienced an allergic reaction after using the ema appliance.After using the appliance for a few days after delivery, the patient developed swelling and ulcers where appliance contacted the inner cheek region, buccal and lingual tissue and lips.
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This is additional data to the data sent in the original file.The following information was not provided by the customer: a2:- patient date of birth; a4:- patient weight; a5:- patient ethnicity; a6:- patient race.B2:- this harm was not considered to be an adverse event since the incident did not result in death or serious injury and does not have the likelihood to result in death or serious injury to a customer.This is being reported out of an abundance of caution and as per guidance by an fda inspector who advised that the fda might be interested in the data for trending purposes.B3:- the date of event was not provided by the customer.D4:- for ematd12010 the lot # is td092419, udi# (b)(4), expiry date = sept 24 2022; for emabp the lot# is bpb111819, udi# (b)(4), expiry date = nov 18, 2022; for emabn2 the lot # is bn2110519, udi # (b)(4), expiry date = nov 5, 2022; for emast21ym the lot# is s060320, udi# (b)(4), expiry date = jun 9 2023.F9:- the date that the custom fit device was made is unknown.No information was provided by the dental laboratory.
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