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

Model Number EMATD12010 EMABN2 EMABP EMAST

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

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 disorder.It is unclear when the patient first received the device, when the reaction occurred and how long the symptoms lasted.The patient experienced a rash on the gingiva area.

Manufacturer Narrative

The following information was not provided by the customer: patient age and date of birth.Patient sex.Patient weight.Patient ethnicity.Patient race.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.Date of event- this information is unknown as it was not provided by the customer.The lot number for product ematd12010 -td040318.The lot number for product emabn2 is bn2050918.The lot number for product.The lot number for product emabp is bp050918, emast is not available, this information was not provided by the customer.Expiry date for ematd12010 is apr/03/2021.Expiry date for emabn2 is may/09/2021.Expiry date for emabp is may/09/2021.Expiry date for emast19bf is not available, this information was not provided by the customer.Udi # for emast is not available, this information was not provided by the customer.The age of the custom device was not provided by the customer.Other note: the incident occurred in 2021 but the initial importer and manufacturer were only made aware in june 2022.

• 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: 15032745
• MDR Text Key: 296042833
• Report Number: 3003928050-2022-00006
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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 EMAST
• Device Lot Number: SEE SECTION H10 FOR MORE DATA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2022
• Event Location: Home
• Date Report to Manufacturer: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1