FDA Adverse Event
Malfunction
Summary report: N
INDURA CATHETER
MDR report key: 1000714
·
Received February 15, 2008
Report
- Report Number
- 6000030-2008-00767
- Event Type
- Malfunction
- Date Received
- February 15, 2008
- Date of Event
- December 7, 2004
- Report Date
- February 24, 2005
- Manufacturer
- RICE CREEK MFG
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
THE HCP REPORTED THE PT WAS HAVING SYMPTOMS OF NAUSEA, VOMITING AND FATIGUE. A DYE STUDY REVEALED THE CATHETER WAS LEAKING. THE PT UNDERWENT PUMP REPLACEMENT (BATTERY DEPLETION) AND CATHETER REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDURA CATHETER | LKK | RICE CREEK MFG | 8709 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Hospitalization| R |