FDA Adverse Event
Malfunction
Summary report: N
CALAXO SCREW
MDR report key: 1000308
·
Received February 14, 2008
Report
- Report Number
- 1219602-2008-00038
- Event Type
- Malfunction
- Date Received
- February 14, 2008
- Report Date
- February 12, 2008
- Manufacturer
- SMITH & NEPHEW INC. ENDOSCOPY DIVISION
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT HAS HAD A REACTION OF THE SCREW AND REPORTS INFLAMMATION AND PAIN OVER THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO SCREW | CALAXO | HWC | SMITH & NEPHEW INC. ENDOSCOPY DIVISION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |