MAUDE Adverse Event Report: CEMENT; CEMENT, DENTAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Inflammation (1932); Local Reaction (2035); Skin Irritation (2076); Swelling (2091); Shaking/Tremors (2515)

Event Date 10/31/2019

Event Type  Injury  

Event Description

Pt called to report an adverse reaction to a cement used while getting a temporary crown.Pt stated that on (b)(6) 2019, she had her first appt for a temporary crown and believes she had a reaction to the cement used.Pt said she experienced small sores inside her mouth.Pt stated she went back on (b)(6) 2019, and the dental assistant told her they were going to give her stronger cement.Pt said her reaction got worse, inside her mouth was inflamed, the veins in her mouth became swollen, she was cold and shaky, and had chest pain.Pt suspects the cement is what caused her adverse reaction.

• Brand Name: CEMENT
• Type of Device: CEMENT, DENTAL
• MDR Report Key: 9699781
• MDR Text Key: 179296326
• Report Number: MW5092950
• 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: Patient
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR