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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DIY DENTURE KIT; DENTURE REPAIR KIT
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DIY DENTURE KIT; DENTURE REPAIR KIT Back to Search Results
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Event or Problem Description
Diy denture kit.This product is harmful for patient and will cause damage and injury that will require thousands of dollars in dentists fee to repair damage if possible at all.Diy(b)(6); fda safety report id# (b)(4).
 
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Brand Name
DIY DENTURE KIT
Common Device Name
DENTURE REPAIR KIT
MDR Report Key11938556
Report NumberMW5101708
Device Sequence Number1248892
Product Code EBO
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Voluntary
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age50 YR
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