FDA Adverse Event
Injury
Summary report: N
HYDROSET ORTHO 15CC
MDR report key: 919124
·
Received September 25, 2007
Report
- Report Number
- 8010177-2007-00044
- Event Type
- Injury
- Date Received
- September 25, 2007
- Date of Event
- July 24, 2007
- Report Date
- August 29, 2007
- Manufacturer
- STRYKER OSTEOSYNTHESIS
- Product Code
- KWI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT, "EXCESSIVE SWELLING WAS SEEN AROUND THE SURGERY SITE. DRAINAGE WAS SEEN W/FIBRONOUS EXODUS FORMATION." HSET WAS REMOVED FROM PATIENT. IT WAS PLACED IN THE FOREARM AND NO MESH OR DRAIN WAS PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROSET ORTHO 15CC | IMPLANT | KWI | STRYKER OSTEOSYNTHESIS | 6A55R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |