MAUDE MDR 9391997
- MDR report key
- 9391997
- Report number
- 1644408-2019-01163
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-10-30
- Date received
- 2019-11-29
- 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 | X-ALT HIGHLY HIP | LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM | ENCORE MEDICAL L.P. | LPH | 932-32-750 | 932-32-750 | 811N1948 | | | | R
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2019-11-29 | 0 | 1. R
|
Event Narratives#
No narrative records found.