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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MYERSON COMPANY LIMITED EMA; ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE
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MYERSON COMPANY LIMITED EMA; ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE Back to Search Results
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); Swelling (2091)
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.
 
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.B3:- 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.F9:- the date that the custom fit device was made is unknown.No information was provided by the dental laboratory.
 
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Brand Name
EMA
Type of Device
ELASTIC MANDIBULAR ADVANCEMENT APPLIANCE
Manufacturer (Section D)
MYERSON COMPANY LIMITED
3 trinity avenue
laventille, 00000
TD  00000
MDR Report Key10984475
MDR Text Key220716519
Report Number3003928050-2020-00001
Device Sequence Number1
Product Code LRK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/12/2020,11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberEMATD12010, EMABP, EMABN2, EMAST21YM
Device Lot NumberSEE SECTION H10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/11/2020
Event Location Home
Date Report to Manufacturer11/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
Patient SexFemale
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