MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-01-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-6XX manufactured by Abbeymoor Medical Inc..
[1732856]
The physician reported that one of his spanner patients had developed sepsis. The pt was admitted with (b)(6) to icu and was hospitalized from (b)(6) 2010. The spanner was initially placed on (b)(6) 2010, for urinary retention. Sepsis was diagnosed on (b)(6) 2010, the day the stent was removed. The pt is currently is a rehab hospital.
Patient Sequence No: 1, Text Type: D, B5
[8971576]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00007 |
| MDR Report Key | 1971890 |
| Report Source | 05 |
| Date Received | 2011-01-17 |
| Date of Report | 2011-01-14 |
| Date of Event | 2010-11-30 |
| Date Mfgr Received | 2010-12-21 |
| Date Added to Maude | 2012-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 501 EAST SOO STREET |
| Manufacturer City | PARKERS PRAIRIE MN 56361 |
| Manufacturer Country | US |
| Manufacturer Postal | 56361 |
| Manufacturer Phone | 2183386700 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THE SPANNER TEMPORARY PROSTATIC STENT |
| Generic Name | TEMPORARY PROSTATIC STENT |
| Product Code | NZC |
| Date Received | 2011-01-17 |
| Model Number | SPNR-6XX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2011-01-17 |