MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-22 for ENCORE VTU-1 NONE manufactured by Encore, Div. Of Wetoo, Inc..
[181353]
While attempting to help erectile dysfunction problem on two separate occasions: rptr caused permanent damage to penis, when using the encore vtui erection device. The vacuum pump and constriction rings severely bruised penis, causing a plaque build-up known as peyronie's disease, which causes a severe curvature to the penis preventing rptr from having intercourse with his wife.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019760 |
| MDR Report Key | 292050 |
| Date Received | 2000-08-22 |
| Date of Report | 2000-08-17 |
| Date of Event | 1998-11-06 |
| Date Added to Maude | 2000-08-25 |
| 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 | 0 |
| 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 | ENCORE VTU-1 |
| Generic Name | VACUUM ERECTION DEVICE |
| Product Code | LKY |
| Date Received | 2000-08-22 |
| Model Number | NONE |
| Catalog Number | NONE |
| Lot Number | NONE |
| ID Number | NONE |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 282667 |
| Manufacturer | ENCORE, DIV. OF WETOO, INC. |
| Manufacturer Address | P.O. BOX 740668 DALLAS TX 753740668 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2000-08-22 |