MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-18 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-6HA manufactured by Abbeymoor Medical Inc..
[1252375]
While soliciting product performance feedback from a pt, the device mfr learned the pt had gone to the emergency room (er) for burning on urination four days after spanner insertion. The pt was given antibiotics for a urinary track infection; the spanner stent was not removed. The pt stated he was feeling better by the next morning. He contacted the nurse at the physician's office to notify them, they stated that this was fine and that he didn't need to come in for any special follow-up. The spanner stent was inserted on (b)(6) 2009. Indication for use was urinary retention. Device removal date is unk but the physician stated the stent was removed as schedule with no untoward adverse effects.
Patient Sequence No: 1, Text Type: D, B5
[8300112]
The device was not returned for analysis. Method - not applicable (actual device were not evaluated). Conclusions - device not returned - no eval will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2009-00003 |
| MDR Report Key | 1542584 |
| Report Source | 05 |
| Date Received | 2009-11-18 |
| Date of Report | 2009-11-18 |
| Date of Event | 2009-10-05 |
| Date Mfgr Received | 2009-10-08 |
| Device Manufacturer Date | 2009-07-01 |
| Date Added to Maude | 2011-04-04 |
| 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 | 2009-11-18 |
| Model Number | SPNR-6HA |
| Lot Number | 216 |
| Device Expiration Date | 2012-07-01 |
| 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 | 2009-11-18 |