MAUDE MDR 9857146
- MDR report key
- 9857146
- Report number
- 0001822565-2020-01023
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-09-12
- Date received
- 2020-03-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | GEL-ONE X-LINKED HYALUR 3ML | BIOLOGICS | SEIKAGAKU CORPORATION | MOZ | | 00111100100 | 0019F07G | | | | *
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2020-03-19 | 0 | 1. O
|
Event Narratives#
No narrative records found.