MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-25 for DENTAL AMALGAM manufactured by Unknown.
[87197173]
(b)(4). Chronic infections, abnormal lab work, chronic pain, allergies, gastritis with no know cause, chronic headaches, fibromyalgia, chest pains, sinus arrythmias and other health problems. Device was covered by insurer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072336 |
| MDR Report Key | 6889774 |
| Date Received | 2017-09-25 |
| Date of Report | 2017-06-23 |
| Date of Event | 2013-06-28 |
| Date Added to Maude | 2017-09-25 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | DENTAL AMALGAM |
| Product Code | EKH |
| Date Received | 2017-09-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Deathisabilit | 2017-09-25 |