MAUDE Adverse Event Report: GC CORP. MI PASTE; PROPHY PASTE

Device Problem Insufficient Information (3190)

Patient Problem Chest Pain (1776)

Event Type  Injury  

Event Description

Gc america received a report from a patient's doctor that the patient was experiencing chest pains after one use of mi paste.The reporter stated that the patient has a pacemaker and a significant cardiac medical history.Patient's doctor stated that she was unsure of what caused the reaction, and requested more information on the product.The reporter refused to provide more patient information.No further investigation can be done without lot number or sample.No additional information was available.

• Brand Name: MI PASTE
• Type of Device: PROPHY PASTE
• Manufacturer (Section D): GC CORP.; 76-1 hasunuma-cho, itabashi-ku; tokyo 174 ; JA 174
• Manufacturer (Section G): GC AMERICA, INC.; 3737 west 127th st.; alsip IL 60803
• Manufacturer Contact: 3737 west 127th st.; alsip, IL 60803
• MDR Report Key: 5340314
• MDR Text Key: 35004297
• Report Number: 1410097-2015-00006
• Device Sequence Number: 1
• Product Code: EJR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2015
• Distributor Facility Aware Date: 12/15/2015
• Event Location: Home
• Date Report to Manufacturer: 12/17/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other