MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-05-30 for THE SPANNER TEMPORARY PROSTATIC STENT SPNR SPNR-5C manufactured by Abbeymoor Medical, Inc..
[871064]
During abbeymoor medical review of a physician provided cystoscopy video, the device manufacturer observed a complete device migration. The device was initially positioned on 12/19/2007 and removed by cystoscopy in early 2008. No known patient injury or hospitalization. No device lot number provided. Indication for use is differential diagnosis. Number of days the spanner had been in use is 35 days.
Patient Sequence No: 1, Text Type: D, B5
[8085816]
The device was not returned for evaluation. Physician feedback suggests the patient, who resided in a nursing home, was doing okay while wearing the spanner. The physician suspects that nursing home personnel may have attempted insertion of a catheter into the patient, thereby pushing the spanner up into the bladder. This form fda 3500a 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 the mdr was not required for this event based on results of a clinician-based risk assessment).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005249627-2008-00004 |
| MDR Report Key | 1056491 |
| Report Source | 05,07 |
| Date Received | 2008-05-30 |
| Date of Report | 2008-05-29 |
| Date of Event | 2008-01-23 |
| Date Mfgr Received | 2008-02-04 |
| Date Added to Maude | 2008-11-10 |
| 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 E 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 | 2008-05-30 |
| Model Number | SPNR |
| Catalog Number | SPNR-5C |
| ID Number | 2009004-5C |
| 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 | 1267940 |
| Manufacturer | ABBEYMOOR MEDICAL, INC. |
| Manufacturer Address | 501 E SOO STREET PARKERS PRAIRIE MN 56361 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-30 |