FDA Adverse Event
Other
Summary report: N
CALAXO - UNKNOWN
MDR report key: 1082969
·
Received July 25, 2008
Report
- Report Number
- 1219602-2008-00183
- Event Type
- Other
- Date Received
- July 25, 2008
- Report Date
- June 23, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RECALL INITIATED IN 2007. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REVIEW OF THE COMPLAINT AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE COMPLETED IF NECESSARY.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT EXPERIENCED UNKNOWN POST-OP CONDITION WITH CALAXO SCREW. NO DETAILS HAVE BEEN PROVIDED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO - UNKNOWN | CALAXO SCREW | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |