MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-04-23 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-8C manufactured by Abbeymoor Medical Inc..
[1521100]
Physician reported he'd seen a patient in the emergency room during the night that had gone into urinary retention while wearing the spanner stent. The stent had been placed the previous day ((b) (6) 2007); one week post transurethral microwave thermotherapy (tumt). The physician was unable to retrieve the removal suture and had to place a foley catheter which pushed the spanner stent into the patient's bladder. The spanner stent was removed by cystoscopy; approximate date of removal was (b) (6) 2007. There were no issues with the removal.
Patient Sequence No: 1, Text Type: D, B5
[8470192]
The device was not returned for evaluation. A review of device history records (dhr) was not performed due to the lot number not being provided. Actual devices were not evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2010-00002 |
| MDR Report Key | 1667606 |
| Report Source | 05 |
| Date Received | 2010-04-23 |
| Date of Report | 2010-04-23 |
| Date of Event | 2007-09-15 |
| Date Mfgr Received | 2007-09-17 |
| Date Added to Maude | 2010-04-29 |
| 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 | MER |
| Date Received | 2010-04-23 |
| Model Number | SPNR-8C |
| 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. Required No Informationntervention | 2010-04-23 |