• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNKNOWN CLEAR DENTAL MATRIX BAND; RETAINER, MATRIX Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CLEAR DENTAL MATRIX BAND
Type of Device
RETAINER, MATRIX
Manufacturer (Section D)
UNKNOWN
MDR Report Key15856708
MDR Text Key304308599
Report NumberMW5113460
Device Sequence Number1
Product Code ECR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/22/2022
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient SexMale
Patient Weight92 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
-
-