MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2005-10-17 for VESICA PERCUTANEOUS BLADDER NECK SUSPENSION KIT * 000-820 manufactured by Boston Scientific Corp..
[411931]
The complainant has reported that a female pt underwent a therapeutic vesica percutaneous bladder neck suspension sling placement approximately 8 years ago. The pt experienced an infection. Specific details on nature and duration of infection time line are not available. In 2005 the pt had the sling removed via a mid-line incision. The procedure was noted to be successful. No further info is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000043-2005-00090 |
| MDR Report Key | 641498 |
| Report Source | 05,06,07 |
| Date Received | 2005-10-17 |
| Date of Report | 2005-10-13 |
| Date of Event | 2005-10-11 |
| Date Mfgr Received | 2005-10-14 |
| Date Added to Maude | 2005-10-19 |
| 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 | 3 |
| 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 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | 780 BROOKSIDE DRIVE |
| Manufacturer City | SPENCER IN 47460 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47460 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VESICA PERCUTANEOUS BLADDER NECK SUSPENSION KIT |
| Generic Name | BLADDER NECK SUSPENSION |
| Product Code | FHK |
| Date Received | 2005-10-17 |
| Model Number | * |
| Catalog Number | 000-820 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 631006 |
| Manufacturer | BOSTON SCIENTIFIC CORP. |
| Manufacturer Address | 780 BROOKSIDE DR. SPENCER IN 47460 US |
| Baseline Brand Name | VESICA PERCUTANEOUS BLADDER NECK SUSPENSION KIT |
| Baseline Generic Name | BLADDER NECK SUSPENSION |
| Baseline Model No | * |
| Baseline Catalog No | 000-820 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-10-17 |