MAUDE Adverse Event Report: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC TEMPLATE ULTRA QUICK MATRIX MATERIAL; MATERIAL, IMPRESSION

Lot Number 733732D

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); No Code Available (3191)

Event Date 07/25/2019

Event Type  Injury  

Event Description

Patient swallowed small piece of dental impression material during procedure and reported indigestion immediately and 3 days of rectal bleeding following that visit.Patient not sure of cause; coincidental?? not sure - several impressions.Can be taken w / cartridge of material.Used to make template for temporary dental crown.

• Brand Name: TEMPLATE ULTRA QUICK MATRIX MATERIAL
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): CLINICIAN'S CHOICE DENTAL PRODUCTS, INC
• MDR Report Key: 8912698
• MDR Text Key: 155099673
• Report Number: MW5089202
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/07/2019

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Lot Number: 733732D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR