MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for POSAT-T-VAC PUMP manufactured by Pos-t-vac Inc..
[111161547]
Patient stated the use of the vacuum pump caused him damage. His erection did not feel natural. Patient had scar tissue and his penis no longer stands up all caused by the use of the vacuum pump. Patient has stopped using the vacuum pump.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077827 |
| MDR Report Key | 7600499 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2017-12-08 |
| Date Added to Maude | 2018-06-14 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POSAT-T-VAC PUMP |
| Generic Name | DEVICE, EXTERNAL PENILE RIGIDITY |
| Product Code | LKY |
| Date Received | 2018-06-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | POS-T-VAC INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-13 |