MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-05-09 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR-6C manufactured by Abbeymoor Medical Inc..
[16370050]
While soliciting product performance feedback from clinicians, the device mfr learned of a device migration event followed by acute urinary retention (aur). Device migration into the bladder was confirmed by x-ray. A foley catheter was inserted to restore bladder drainage. Cystoscopic removal of the device was performed. No pt injury was reported. No pt info or device lot number was provided. Indication for use is unk. Number of days the spanner had been in use is unk.
Patient Sequence No: 1, Text Type: D, B5
[16649810]
The device was not returned for evaluation. A review of device history records (dhr) for relevant spanner lots revealed no indication that the device used did not meet specifications. This form fda is being submitted after the required 30-day time frame in response to recent interactions between abbeymoor, the fda local district office, and the fda reporting systems monitoring branch in which migration events with cystoscopic removal were deemed mdr reportable. (abbeymoor initially determined that a mdr was not required for this event based on results of a clinician-based risk assessment. ) explanation of evaluation codes used.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00001 |
| MDR Report Key | 1041249 |
| Report Source | 05 |
| Date Received | 2008-05-09 |
| Date of Report | 2008-05-07 |
| Date of Event | 2006-12-01 |
| Date Mfgr Received | 2007-01-03 |
| Date Added to Maude | 2009-05-15 |
| 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 | 2008-05-09 |
| Model Number | SPNR-6C |
| ID Number | 2009004-6C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2008-05-09 |