MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-06-20 for VASCLIP * manufactured by Vmbc, Llc.
[448285]
Add'l info rec'd from mfr 10/11/04: in closing, the issue related to report number mw1032627 are not vasclip product related, there is no evidence of any product failure in this case, the product has not been returned as requested to the company for analysis, and no semen analysis results have been provided to the company after november 12, 2003. We believe the repeat procedure is specifically related to this specific physician's lack of awareness and understanding of semen analysis after a vasectomy (or vasclip) procedure. With the support of american urological association member, we are making every effort within our limited financial means to see that pts and physicians understand the need for proper semen analysis testing a vasectomy or vasclip procedure.
Patient Sequence No: 1, Text Type: D, B5
[19164309]
Pt had a recently fda approved vasclip inserted in them as an alternative to a vasectomy. In approx august of 2003, after a semen analysis showed no presence of sperm and getting the go ahead from dr pt and spouse having unprotected sex. In november of 2003 pt's spouse became pregnant and a subsequent semen analysis showed the presence of sperm. One event that may be related is that in approx october of 2003 pt had blood in their ejaculation. However, after an exam by dr and a phone consulation with dr, both assured them it was unrelated to the vasclip and pt could continue having unprotected sex. 2004 pt underwent a standard vasectomy and had the vasclips removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032627 |
| MDR Report Key | 541378 |
| Date Received | 2004-06-20 |
| Date of Report | 2004-06-20 |
| Date of Event | 2003-04-30 |
| Date Added to Maude | 2004-09-01 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VASCLIP |
| Generic Name | VASECTOMY DEVICE |
| Product Code | NJC |
| Date Received | 2004-06-20 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 530714 |
| Manufacturer | VMBC, LLC |
| Manufacturer Address | 3030 CENTRE POINTE DR SUITE 900 ROSEVILLE MN 55113 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-06-20 |