FDA Adverse Event
Other
Summary report: N
CALAXO - UNKNOWN
MDR report key: 1001471
·
Received February 19, 2008
Report
- Report Number
- 1219602-2008-00025
- Event Type
- Other
- Date Received
- February 19, 2008
- Report Date
- January 4, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
NO PROD IS BEING RETURNED FOR EVAL.
Description of Event or Problem · 1
PT HAD TO HAVE ANOTHER PROCEDURE TO REMOVE SOME OF THE SCREW. NO OTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO - UNKNOWN | CALAXO | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |