MAUDE Adverse Event Report: UNKNOWN CLEAR DENTAL MATRIX BAND; RETAINER, MATRIX

Device Problem Melted (1385)

Patient Problem Pain (1994)

Event Date 02/18/2022

Event Type  Injury  

Event Description

Unknown to me, a clear dental matrix band was put and left in my mouth.The band is dissolving inside my mouth.The plastic sticks to my teeth and gum causing extreme pain.When i visit dentists for assistance, they tell me "i can't see it".It's made from clear plastic, designed not to be seen.I do not believe fda would allow doctors to put untraceable foreign into my mouth.I need help getting this thing out.It causes pain 24-7.Fda safety report id #(b)(4).

• Brand Name: CLEAR DENTAL MATRIX BAND
• Type of Device: RETAINER, MATRIX
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 15856708
• MDR Text Key: 304308599
• Report Number: MW5113460
• Device Sequence Number: 1
• Product Code: ECR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American