MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-17 for VAS CLIP * manufactured by Vmbc Llc.
[17487091]
Reports wife now pregnancy after zero sperm count on 1st semen analysis, vasclip applied 3 months prior. This is second late failure and pregnancy in my limited use of the device. Estimate 25 or fewer pts in 5 years.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042635 |
| MDR Report Key | 840662 |
| Date Received | 2007-04-17 |
| Date of Report | 2007-04-05 |
| Date of Event | 2007-03-01 |
| Date Added to Maude | 2007-04-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAS CLIP |
| Generic Name | * |
| Product Code | NJC |
| Date Received | 2007-04-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 827949 |
| Manufacturer | VMBC LLC |
| Manufacturer Address | * WHITE BEAR LAKE MN 55110 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-04-17 |