MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-12 for TOROSA 5206502400 manufactured by Coloplast A/s.
[4428967]
As reported to coloplast though not verified, patient was implanted with torosa saline testicular (large). Later the patient experienced an explant of the device due to device deflation.
Patient Sequence No: 1, Text Type: D, B5
[11930790]
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2014-00368 |
| MDR Report Key | 3899181 |
| Report Source | 04 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-05-12 |
| Date of Event | 2014-04-08 |
| Date Mfgr Received | 2014-04-14 |
| Device Manufacturer Date | 2011-11-17 |
| Date Added to Maude | 2014-06-30 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA KILIAN, HEAD OF RA |
| Manufacturer Street | 1601 W RIVER ROAD N |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6122874236 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1525 WE RIVER ROAD N |
| 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 |
| Product Code | FAF |
| Date Received | 2014-05-12 |
| Model Number | 5206502400 |
| Catalog Number | 5206502400 |
| Lot Number | 3032156 |
| Device Expiration Date | 2016-10-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST A/S |
| Manufacturer Address | HOLTEDAM-1 HUMLEBAEK DA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-12 |