FDA Adverse Event
Injury
Summary report: N
DENTAL AMALGAM
MDR report key: 6399483
·
Received March 13, 2017
Report
- Report Number
- MW5068421
- Event Type
- Injury
- Date Received
- March 13, 2017
- Date of Event
- January 3, 2017
- Report Date
- January 8, 2017
- Manufacturer
- UNKNOWN
- Product Code
- EKH
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4). HAD AMALGAM FILLING REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182619 | DENTAL AMALGAM | EKH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47.000 YR | Life Threatening| R| S |