MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2015-03-30 for TOROSA 5206302400 450-1327 manufactured by Coloplast A/s.
[19359812]
As reported to coloplast. Though not verified, the patient was implanted with a torosa saline filled testicular prosthesis. Later the patient experienced that the prothesis had deflated. An explant of the device was performed.
Patient Sequence No: 1, Text Type: D, B5
[19772549]
Because the available information provided indicated "leaking" may have contributed to the device not working as intended/device deflation, and because no secondary injection site was noted in the injection port and no crystalized residue was present in the device, qa determined that the device was most likely implanted without being properly filled with saline according to the ifu instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2015-00042 |
| MDR Report Key | 4642588 |
| Report Source | 01,04 |
| Date Received | 2015-03-30 |
| Date of Report | 2015-03-30 |
| Date of Event | 2015-02-18 |
| Date Mfgr Received | 2015-03-02 |
| Device Manufacturer Date | 2014-08-18 |
| Date Added to Maude | 2015-03-31 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 PROTHESIS |
| Product Code | FAF |
| Date Received | 2015-03-30 |
| Returned To Mfg | 2015-03-27 |
| Model Number | 5206302400 |
| Catalog Number | 450-1327 |
| Lot Number | 4254879 |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-03-30 |