FDA Adverse Event
Other
Summary report: N
THE SPANNER TEMPORARY PROSTATIC STENT
MDR report key: 1971872
·
Received January 17, 2011
Report
- Report Number
- 3005249627-2010-00008
- Event Type
- Other
- Date Received
- January 17, 2011
- Date of Event
- August 9, 2010
- Report Date
- January 14, 2011
- Manufacturer
- ABBEYMOOR MEDICAL INC.
- Product Code
- NZC
- PMA / PMN Number
- P060010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DHR WAS NOT PERFORMED. EVERY DEVICE LOT IS VERIFIED AS STERILE BEFORE RELEASE INTO INVENTORY URINARY TRACT INFECTIONS ARE NOT A SIGNIFICANT RATE OF OCCURRENCE.
Description of Event or Problem · 1
THE PHYSICIAN REPORTED ONE OF HIS SPANNER PATIENTS HAD DEVELOPED SEPSIS. THE SPANNER WAS INITIALLY PLACED ON (B)(6) 2010, FOR RETENTION. SPANNER STENT WAS REMOVED ON (B)(6) 2010. THE PT WAS HOSPITALIZED FOR ONE DAY; THE DAY AFTER SPANNER REMOVAL ((B)(6) 2010). THE PT IS CURRENTLY DOING FINE AND IS WEARING ANOTHER SPANNER STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THE SPANNER TEMPORARY PROSTATIC STENT | TEMPORARY PROSTATIC STENT | NZC | ABBEYMOOR MEDICAL INC. | SPNR-8HA | 00256 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |