MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-11 for GLASS IONOMER LUTING CEMENT 441000 manufactured by Gc Corporation -fuji Oyama Factory.
[132911743]
We will review ifu of the device to determine improvement of the information on potential allergens.
Patient Sequence No: 1, Text Type: N, H10
[132911744]
The patient recently had allergy testing done and determined to have allergies to some of the ingredients in dental material ie 2 hydroxyethyl methacrylate , polymethylmethacrylate and amiodarone. Dr. Reported on (b)(6) 2019 that the patient had a strong reaction to hema ( hydroxyethyl methacrylate). Her symptoms have been a reoccurring facial rash. The patient is being treated with facial cream. Dr. Is evaluating if cream will resolve the problem. If not, will then consider to remove the restoration with 3 unit bridge. The most recent one was placed with fujicem 2 in 2016. They do not know what other cements were used on her other restorations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1410097-2019-00001 |
| MDR Report Key | 8241882 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-11 |
| Date of Report | 2019-01-11 |
| Date of Event | 2018-12-14 |
| Date Facility Aware | 2018-12-14 |
| Date Mfgr Received | 2018-12-14 |
| Date Added to Maude | 2019-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLASS IONOMER LUTING CEMENT |
| Generic Name | GC FUJICEM 2 |
| Product Code | EMA |
| Date Received | 2019-01-11 |
| Catalog Number | 441000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GC CORPORATION -FUJI OYAMA FACTORY |
| Manufacturer Address | 584-1 NAKAHINATA OYAMA-CHO, SUNTO-GUN SHIZUOKA-KEN, 410-1307 JA 410-1307 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-11 |