FDA Adverse Event
Other
Summary report: N
TUNA
MDR report key: 511569
·
Received February 9, 2004
Report
- Report Number
- 2950887-2004-00165
- Event Type
- Other
- Date Received
- February 9, 2004
- Date of Event
- April 4, 2003
- Report Date
- February 9, 2004
- Manufacturer
- MEDTRONIC GASTROENTEROLOGY/UROLOGY
- Product Code
- KNS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION FOLLOWING A TUNA PROCEDURE. URINE CULTURES REVEALED PSEUDOMONAS AERUGINOSA AND THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE INFECTIONS SUBSEQUENTLY RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TUNA | EEU | KNS | MEDTRONIC GASTROENTEROLOGY/UROLOGY | 7900TU | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O |