MAUDE Adverse Event Report: THE MYERSON COMPANY LIMITED EMA; ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE

Model Number EMATD12010, EMABN2, EMABP,EMAST19BF

Device Problems Biocompatibility (2886); Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/03/2021

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

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 5-3-21.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.

• Brand Name: EMA
• Type of Device: ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE
• Manufacturer (Section D): THE MYERSON COMPANY LIMITED; 3 trinity avenue; laventille, port of spain 00000 ; TD 00000
• MDR Report Key: 14845777
• MDR Text Key: 295071008
• Report Number: 3003928050-2022-00003
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EMATD12010, EMABN2, EMABP,EMAST19BF
• Device Lot Number: SEE H10 FOR MORE DATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 06/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1