MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-07-17 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR- manufactured by Abbeymoor Medical Inc..
[20823910]
The device was not returned for eval. The device mfr has been provided with no info regarding the device procedure, indications, removal, or treatment. Attempts to gain further info regarding this event from the pt's physician were unsuccessful. Cause of retention and hematuria is unk.
Patient Sequence No: 1, Text Type: N, H10
[20837240]
While soliciting product performance feedback from the pt, the device mfr learned the stent was removed in the emergency room due to urinary occlusion nine hours after placement. The pt passed a trial void after device placement but was unable to urinate thereafter. The cause of the occlusion was not identified. Method of device removal and treatment is unk. Pt experienced hematuria for 3 days following removal. Indication for use and device lot number are unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005249627-2008-00009 |
| MDR Report Key | 1078555 |
| Report Source | 00 |
| Date Received | 2008-07-17 |
| Date of Report | 2008-07-17 |
| Date of Event | 2008-04-25 |
| Date Mfgr Received | 2008-04-30 |
| Date Added to Maude | 2008-07-24 |
| 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 | 2008-07-17 |
| Model Number | SPNR- |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1046158 |
| Manufacturer | ABBEYMOOR MEDICAL INC. |
| Manufacturer Address | 501 EAST SOO STREET PARKERS PRAIRIE MN 56361 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-07-17 |