MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-12 for TOROSA SIZE 2.7X 4.0 CM 450-1327 manufactured by Coloplast Corp..
[49246591]
Patient Sequence No: 1, Text Type: N, H10
[49246592]
The patient underwent removal of his left testicle due to left testicular tumor. The patient had a prosthesis placed at time of removal (device in question). Surgeon was notified postoperatively that the implanted prosthesis had failed and had deflated. The exact timeline of the failure is unknown, but it is believed failure occurred within 1 week of implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5784816 |
| MDR Report Key | 5784816 |
| Date Received | 2016-07-12 |
| Date of Report | 2016-06-29 |
| Date of Event | 2016-02-05 |
| Report Date | 2016-06-29 |
| Date Reported to FDA | 2016-06-29 |
| Date Reported to Mfgr | 2016-06-29 |
| Date Added to Maude | 2016-07-12 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOROSA |
| Generic Name | PROSTHESIS, TESTICULAR |
| Product Code | FAF |
| Date Received | 2016-07-12 |
| Model Number | SIZE 2.7X 4.0 CM |
| Catalog Number | 450-1327 |
| Lot Number | 4837525 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST CORP. |
| Manufacturer Address | 1601 WEST RIVER ROAD MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-12 |