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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event 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
Type of Device
DENTURE REPAIR KIT
MDR Report Key11938556
MDR Text Key254590151
Report NumberMW5101708
Device Sequence Number1
Product Code EBO
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 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
Device Operator Lay User/Patient
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/03/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age50 YR
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