The following information was not provided by the customer: patient date of birth, patient sex, patient weight, patient ethnicity, patient race.Outcomes attributed to adverse event: 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 livelihood 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.The lot number for product ematd12010 is td090120, the lot number for product emabn2 is bn2b093020, the lot number for product emabp is bpb091720, the lot number for product emast19bf is not available, this information was not provided by the customer.Expiry date for ematd12010 -09.01.2023, expiry date for emabn2 is 09.30.2023, expiry date for emabp is 09.17.2023, expiry date for emast19bf is not available, this information was not provided by the customer.Other note: the incident occured in 2021 but the initial importer and manufacturer were only made aware in (b)(6) 2022.
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The distributor, (b)(4), received a report that a patient had an allergic reaction to his / her ema device.Myerson's ema devices are used to help treat sleep apnea disorders.It was reported that the patient first used the device on (b)(6) 2020, however, the reaction did not appear until (b)(6) 2021 (4 months later).It was noted that the patient reported that after a full night of wearing appliance the patient woke up to red, slightly swollen lips and irritation on buccal mucosa-any tissues that came in direct contact with appliance would initially start out red but then with continued wear would start to ulcerate.It was also reported by the patient that he/she would discontinue the use of the appliance for 2-3 days to allow tissues to heal before wearing again.It is unclear if the patient has any pre-existing allergies at this time.
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