MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for TOROSA TESTICULAR PROSTHESIS 450-1329 manufactured by Coloplast A/s.
[62211239]
We would like to bring to the attention of the fda a concern our system has with the labeling of the coloplast testicular implant box. In a procedure done in (b)(6) of 2016 the box label reads "saline filled testicular prosthesis". In reality this implant is not saline filled. Saline must be done manually by the staff. The labeling was misleading.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066633 |
| MDR Report Key | 6166305 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-11-30 |
| Date of Event | 2016-03-18 |
| Date Added to Maude | 2016-12-12 |
| 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 | RISK MANAGER |
| 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 TESTICULAR PROSTHESIS |
| Generic Name | TESTICULAR IMPLANT |
| Product Code | FAF |
| Date Received | 2016-12-07 |
| Catalog Number | 450-1329 |
| Lot Number | 5117418 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-12-07 |