MAUDE Adverse Event Report: DIY DENTURE KIT; DENTURE REPAIR KIT

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).

• Brand Name: DIY DENTURE KIT
• Type of Device: DENTURE REPAIR KIT
• MDR Report Key: 11938556
• MDR Text Key: 254590151
• Report Number: MW5101708
• Device Sequence Number: 1
• Product Code: EBO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR