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  

Manufacturer Narrative

This harm was not considered to be an adverse event.The patient recovered after one (1) day and no other serious implications were noted therefore, 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 td102918, the lot number for product emabn2 is bn2091818, the lot number for product emabp is bp112918, the lot number for product emast is not available, this information was not provided by the customer.Expiry date for ematd12010 is 10-29-2021, expiry date for emabn2 is 09-18-2021, expiry date for emabp is 11-29-2021, expiry date for emast is not available, this information was not provided by the customer.The incident occured in 2021 but the initial importer and manufacturer were only made aware in (b)(6) 2022.

Event Description

The distributor, glidewell, received a report that a patient had a reaction to his / her ema device.It was reported that the appliance was worn for three (3) months.At some time during that period the following allergic reactions occured; swollen, bright red gingiva and tongue.The symptoms went away after a day.It is unclear if the patient has any pre-existing allergies at this time nor any other information regarding the on-set of symptoms experienced.

• 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: 14845873
• MDR Text Key: 295116697
• Report Number: 3003928050-2022-00001
• 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

• 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: 06/01/2022
• Device Age: 3 MO
• Event Location: Home
• Date Report to Manufacturer: 06/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR