FDA Adverse Event
Summary report: N
INTERSEAL IMPACTOR HOLE PLUG
MDR report key: 1799644
·
Received July 23, 2010
Report
- Report Number
- 1043534-2010-00262
- Date Received
- July 23, 2010
- Report Date
- July 8, 2010
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- LPH
- PMA / PMN Number
- K931333
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE #5: INVESTIGATION IS NOT COMPLETE. NO COMPLAINT WAS STATED AGAINST THIS COMPONENT. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00091, 00092, 00260, 000261. THIS EVENT OCCURRED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSEAL IMPACTOR HOLE PLUG | LPH | WRIGHT MEDICAL TECHNOLOGY, INC. | 087448106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |