MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS 3M RELYX; CEMENT, DENTAL

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2009

Event Type  malfunction  

Event Description

Every time i purchase a dental product from this company, it's never the same quality or consistency as what i receive from darby or henry schein.I seriously feel like this company is selling counterfeit or damaged items to their customers.Product type: otc.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes.Did the problem return if the person started taking or using the product again? yes.Frequency: other - dental item.How was it taken or used? topically.Reason for use: oral exam.

• Brand Name: 3M RELYX
• Type of Device: CEMENT, DENTAL
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS
• MDR Report Key: 8731317
• MDR Text Key: 149253903
• Report Number: MW5087591
• Device Sequence Number: 1
• Product Code: EMA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2020
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1