FDA Adverse Event
Malfunction
Summary report: N
CALAXO - UNK
MDR report key: 1010116
·
Received March 10, 2008
Report
- Report Number
- 1219602-2008-00049
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Report Date
- February 4, 2008
- Manufacturer
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT RECALL INITIATED 2007. THIS MEDWATCH REPORT IS BEING COMPLETED TO ADDRESS 10-12 UNIDENTIFIED ISSUES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DR HAS HAD 10-12 PTS WITH CALAXO ISSUES. IT WAS STATED THAT ADD'L DATA WOULD BE FORTHCOMING, BUT NONE HAS TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CALAXO - UNK | CALAXO | HWC | SMITH & NEPHEW INC., ENDOSCOPY DIV. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |