MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for MI PASTE manufactured by Gc Corp..
[35004297]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2015-00006 |
| MDR Report Key | 5340314 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-17 |
| Date Facility Aware | 2015-12-15 |
| Report Date | 2015-12-17 |
| Date Reported to FDA | 2015-12-17 |
| Date Reported to Mfgr | 2015-12-17 |
| Date Added to Maude | 2016-01-04 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal | 60803 |
| Manufacturer G1 | GC AMERICA, INC. |
| Manufacturer Street | 3737 WEST 127TH ST. |
| Manufacturer City | ALSIP IL 60803 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60803 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MI PASTE |
| Generic Name | PROPHY PASTE |
| Product Code | EJR |
| Date Received | 2015-12-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORP. |
| Manufacturer Address | 76-1 HASUNUMA-CHO, ITABASHI-KU TOKYO 174 JA 174 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-12-21 |