MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-09-18 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR manufactured by Abbeymoor Medical Inc..
[19201395]
Physician reported an adverse event in which the spanner device became spontaneously dislodged, and had to be removed from the pt's bladder endoscopically. No complications were reported for the pt, and no follow-up treatment was required. Indication for use was urinary retention. Dates of insertion and removal were not provided.
Patient Sequence No: 1, Text Type: D, B5
[19426291]
The physician stated the event may be related to mechanical defect however, he did not recover the device to send back for analysis. Device size and lot number are unk therefore a review of device history records was not performed. Actual devices were not evaluated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2009-00002 |
| MDR Report Key | 1479296 |
| Report Source | 05 |
| Date Received | 2009-09-18 |
| Date of Report | 2009-09-18 |
| Date Mfgr Received | 2009-08-27 |
| Date Added to Maude | 2009-09-25 |
| 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 | 2009-09-18 |
| 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 E SOO ST PARKERS PRAIRIE MN 56361 US 56361 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-09-18 |