MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-23 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- manufactured by Abbeymoor Medical Inc..
[20214677]
The physician reported one of his spanner pts was hospitalized for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[20580884]
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. Three attempts were made to contact the physician for add'l info, none was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00006 |
| MDR Report Key | 1849042 |
| Report Source | 05 |
| Date Received | 2010-09-23 |
| Date of Report | 2010-09-23 |
| Date of Event | 2010-08-01 |
| Date Mfgr Received | 2010-08-18 |
| Date Added to Maude | 2012-03-15 |
| 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 | 2010-09-23 |
| Model Number | SPNR- |
| 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. Required No Informationntervention | 2010-09-23 |