MAUDE Adverse Event Report: DENTSPLY, LLC AQUASIL POLY-VINYL IMPRESSION MATERIAL; MATERIAL, IMPRESSION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Reaction (2414); Numbness (2415); No Code Available (3191)

Event Date 06/25/2019

Event Type  Injury  

Event Description

I went to (b)(6) to have new dentures made.The dentist used impression material made by dentsply that i had a very bad reaction to.The dentist left the impression material in my mouth for over 18 minutes, my throat became numb and a burning sensation as well as a terrible taste in my mouth overwhelmed me.I began to have dry heaves off and on through the following day.It has been over a week and my mouth still has the burning sensation and mild numbness, as well as the very bad taste.Small white dots are covering my tongue.I called the manufacturer to request the material safety sheet on two separate occasions.They have not completed.The products are aquasil poly-vinyls.Fda safety report id# (b)(4).

• Brand Name: AQUASIL POLY-VINYL IMPRESSION MATERIAL
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): DENTSPLY, LLC
• MDR Report Key: 8767970
• MDR Text Key: 150398079
• Report Number: MW5087913
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/05/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 86