MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-03-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- SPNR-6C manufactured by Abbeymoor Medical Inc..
[1070168]
The patient received a spanner in 2007 for post transurethral microwave thermotherapy (tumt) retention. The patient returned for a follow up visit, per the physician's request about two days later. At that time, the physician performed a transrectal ultrasound (trus) which appeared to show the device may have migrated into the bladder but x-ray showed the spanner had partially migrated. The anchor appeared to be just above the sphincter. The physician repositioned the device anchor and sent the patient home. The patient returned at about one week later, after nine days of spanner wear with low urinary flow, cystoscopy showed a complete migration of the device into the patient's bladder. The physician removed the spanner. No information was provided on how the device was removed or any further follow up with the patient after device removal.
Patient Sequence No: 1, Text Type: D, B5
[8188032]
The device was not returned for evaluation. A review of device history records (dhr) for the relevant spanner lot revealed no indication that the device used did not meet specifications. (actual devices were not evaluated).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2009-00001 |
| MDR Report Key | 1346052 |
| Report Source | 05,07 |
| Date Received | 2009-03-17 |
| Date of Report | 2009-03-13 |
| Date of Event | 2007-07-27 |
| Date Mfgr Received | 2007-07-30 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2009-03-24 |
| 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 | 2009-03-17 |
| Model Number | SPNR- |
| Catalog Number | SPNR-6C |
| Lot Number | 1 |
| Device Expiration Date | 2009-06-30 |
| 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 | 2009-03-17 |