MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-12-03 for UNK * manufactured by Temrex.
[212887]
4 days after having a medial filling placed in a very deep cavity, rptr developed a sudden, debilitating onset of symptoms. It felt like the back of their neck was on fire and like they came down with the worst flu they'd ever had, it progressed to include shortness of breath, nausea, dizziness, vomiting, severe sweats, chills, chest pain. These symptoms continued without letup (while drs examined and told rptr it couldn't have anything to do with their dental work) until this filling was removed. Rptr lost job, was barely able to graduate from college, after previously being "student of the year" immediate 90% improvement upon removal, but still having some neck pain and chronic infections.
Patient Sequence No: 1, Text Type: D, B5
[241028]
Add'l info rec'd from rptr 12/14/01: pt developed skin rashes, hives. Upon removal of this same filling 8 months later, pt had an immediate same day 90% improvement of all symptoms, including the neck pain. Pt has since run across documentation regarding disadvantages of this type of filling material, which says it should never be used in a deep cavity where there is even the slightest chance of it touching the pulp/dentin, as it will cause a "chronic inflammatory response". Pt has also seen where a study has been done of a flu-like condition in dental pts related to this material. Pt is looking for add'l info, since they still have some -minimal- neck pain, and various other problems, although a complete medical workup has revealed nothing. Pt does believe that this procedure was the cause of their sudden, severe onset of puzzling symptoms. It was the only thing pt did different.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1023498 |
| MDR Report Key | 363848 |
| Date Received | 2001-12-03 |
| Date of Report | 2001-12-02 |
| Date of Event | 2001-02-22 |
| Date Added to Maude | 2001-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | TEMPORARY FILLING MIX |
| Product Code | EMB |
| Date Received | 2001-12-03 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 352956 |
| Manufacturer | TEMREX |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2001-12-03 |