MAUDE MDR 9613034
- MDR report key
- 9613034
- Report number
- 2939274-2020-00308
- Event key
- 0
- Event type
- 3
- Date received
- 2020-01-21
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- KARA DITTY-BOVARD
- Address
- 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US
- Phone
- 610-610-6103
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNK - CABLE/WIRE | WIRE, SURGICAL | WRIGHTS LANE SYNTHES USA PRODUCTS LLC | LRN | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-01-21 | 0 |
Event Narratives#
No narrative records found.