MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-01-25 for URETHRAL STENT 800-120 manufactured by *.
[20528195]
Seven days after a therapeutic urethral stent placement for benign urethral stenosis the pt presented with vesicle retention. It was seen on x-ray that the stent had collapsed. The stent was removed with no pt complications and a new stent will be placed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000045-2005-00012 |
| MDR Report Key | 667531 |
| Report Source | 07 |
| Date Received | 2006-01-25 |
| Date of Report | 2005-12-26 |
| Date Mfgr Received | 2005-12-26 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2006-01-26 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760 |
| Manufacturer Phone | 5086834066 |
| Manufacturer G1 | * |
| Manufacturer Street | BALLYBRIT BUSINESS PARK |
| Manufacturer City | GALWAY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | URETHRAL STENT |
| Generic Name | URETHRAL STENT SYSTEM |
| Product Code | MER |
| Date Received | 2006-01-25 |
| Model Number | NA |
| Catalog Number | 800-120 |
| Lot Number | 8097457 |
| ID Number | NA |
| Device Expiration Date | 2006-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 656899 |
| Manufacturer | * |
| Manufacturer Address | BALLYBRIT BUSINESS PARK GALWAY EI |
| Baseline Brand Name | URETHRAL STENT |
| Baseline Generic Name | URETHRAL STENT SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 800-120 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-01-25 |