MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-12-19 for TOROSA 5206502400 manufactured by Coloplast A/s.
[4128171]
As reported to coloplast but not verified, leakage was reported during filling of the implant. A second implant was used and also was found to have a leak. Therefore surgery was not completed.
Patient Sequence No: 1, Text Type: D, B5
[11386230]
After further investigation coloplast was able to confirm the damage to the prothesis which contributing to the leak. Based on this evaluation the root cause appears to be attributed to user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2013-00363 |
| MDR Report Key | 3536499 |
| Report Source | 06 |
| Date Received | 2013-12-19 |
| Date of Report | 2013-11-12 |
| Date of Event | 2013-07-22 |
| Date Mfgr Received | 2013-10-03 |
| Device Manufacturer Date | 2013-05-01 |
| Date Added to Maude | 2013-12-26 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIM CRABTREE, MANAGER |
| Manufacturer Street | 1601 WEST RIVER RD. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024922 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVER RD. 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 |
| Product Code | FAF |
| Date Received | 2013-12-19 |
| Returned To Mfg | 2013-10-23 |
| Model Number | 5206502400 |
| Catalog Number | 5206502400 |
| Lot Number | 3660017 |
| Device Expiration Date | 2008-03-31 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2013-12-19 |