MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-07 for TOROSA SALINE-FILLED TESTICULAR PROSTHESIS 450-1327 520630 manufactured by Coloplast Manufacturing Us, Llc.
[116551486]
I have a torosa saline-filled testicular prosthesis and it deflated hours, and i could feel it denting and consorting in a manner that looked like a thumbprint was pushed in to the implant 48 hrs after implantation. The only reason to get the implant is for cosmetic purposes, however it deflated defeating the entire surgery since the surgeon said he would have to take it out and try again. I couldn't afford it and so i suffer once again having now a deflated prosthetic that is so fake and gross looking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078930 |
| MDR Report Key | 7762402 |
| Date Received | 2018-08-07 |
| Date of Report | 2018-08-03 |
| Date of Event | 2015-08-20 |
| Date Added to Maude | 2018-08-08 |
| 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 | TOROSA SALINE-FILLED TESTICULAR PROSTHESIS |
| Generic Name | PROSTHESIS, TESTICULAR |
| Product Code | FAF |
| Date Received | 2018-08-07 |
| Model Number | 450-1327 |
| Catalog Number | 520630 |
| Lot Number | 2015 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-08-07 |