FDA Adverse Event
Other
Summary report: N
O-Z COIL SPECIAL (OZ C CA2)
MDR report key: 449856
·
Received March 20, 2003
Report
- Report Number
- 1317749-2003-00007
- Event Type
- Other
- Date Received
- March 20, 2003
- Date of Event
- February 14, 2003
- Report Date
- March 12, 2003
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A CUSTOMER HAD A PROBLEM WITH A PERITONEAL DIALYSIS CATHETER. ACCORDING TO THE CUSTOMER THE CATHETER HAD A LEAK 1CM BELOW THE FELT CUFF REQUIRING IMPLANTATION OF A NEW CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | O-Z COIL SPECIAL (OZ C CA2) | PERITONEAL DIALYSIS CATHETER | FJS | TYCO HEALTHCARE/KENDALL | * | 128618 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |