MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for TOROSA 450-1327 manufactured by Coloplast Manufacturing Us, Llc.
[111703307]
Patient Sequence No: 1, Text Type: N, H10
[111703308]
This is a patient that was diagnosed with testicular cancer and had an orchiectomy. He had a testicular prosthesis implanted when the orchiectomy was performed. A few days later it was flat. The patient ended up seeing the urologist in the office and the surgeon had never seen that happen before. The urologist feels like the device is defective. The patient was having to go through chemotherapy and recovering. The patient now feels like he is ready to have this potentially defective device replaced. He is going to go through a procedure at a cancer institute and would like this done at the same time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7619770 |
| MDR Report Key | 7619770 |
| Date Received | 2018-06-20 |
| Date of Report | 2018-06-04 |
| Date of Event | 2017-10-04 |
| Report Date | 2018-06-04 |
| Date Reported to FDA | 2018-06-04 |
| Date Reported to Mfgr | 2018-06-04 |
| Date Added to Maude | 2018-06-20 |
| 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 | 2018-06-20 |
| Catalog Number | 450-1327 |
| Lot Number | 5675336 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | 1601 WEST RIVER ROAD MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-20 |