MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2015-09-04 for TOROSA 5206302400 450-1327 manufactured by Coloplast A/s.
[25066800]
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
[25066801]
As reported to coloplast, though not verified, the patient was implanted with a torosa saline filled testicular prosthesis. Later the patient experienced scrotal pain and irritation and the implant was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2015-00091 |
| MDR Report Key | 5058024 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-05 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LEEANNE SWIRIDOW |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024945 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOROSA |
| Generic Name | SALINE FILLED TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2015-09-04 |
| Model Number | 5206302400 |
| Catalog Number | 450-1327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM 1 HUMLEBAEK, 3050 DA 3050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-04 |