MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-02 for THE SPANNER TEMORARY PROSTATIC STENT SPNR-8 manufactured by .
[2709693]
The patient had an episode of bleeding (gross hematuria) that began after his last spanner insertion on (b)(6) 2012. The bleeding started after the patient mowed his lawn. Physician determined hematuria secondary to spanner trauma. The patient went to the emergency room on (b)(6) 2012, where the spanner was removed without difficulty and a foley catheter was inserted. On (b)(6) 2012 the foley catheter was removed and another spanner was placed.
Patient Sequence No: 1, Text Type: D, B5
[9849911]
The device was not returned for analysis. No device malfunction was reported. A review of the dhr was not performed due to the lot number not being provided. Actual device not evaluated. No evaluation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2012-00001 |
| MDR Report Key | 2573806 |
| Report Source | 05 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-04-30 |
| Date of Event | 2012-03-31 |
| Date Mfgr Received | 2012-04-11 |
| Date Added to Maude | 2012-08-03 |
| 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 TEMORARY PROSTATIC STENT |
| Generic Name | TEMPORARY PROSTATIC STENT |
| Product Code | NZC |
| Date Received | 2012-05-02 |
| Model Number | SPNR-8 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-02 |