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

Model Number EMATD12010, EMABP, EMABN2, EMAST21YM

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Ulcer (2274); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.D3:- 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 h4:- the date that the custom fit device was made is unknown.No information was provided by the dental laboratory.

• Brand Name: EMA
• Type of Device: ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE
• Manufacturer (Section D): MYERSON COMPANT LIMITED; 3 trinity avenue; laventille, 00000 ; TD 00000
• Manufacturer (Section G): MYERSON COMPANY LIMITED; 3 trinity avenue; laventille, 00000 ; TD 00000
• Manufacturer Contact: cindy buchoon - legendre ; 5106 north ravenswood; chicago, IL 60640-2713 ; 3124328200
• MDR Report Key: 10984480
• MDR Text Key: 220700312
• Report Number: 3004588608-2020-00001
• Device Sequence Number: 1
• Product Code: LRK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EMATD12010, EMABP, EMABN2, EMAST21YM
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female