MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-05-29 for TEROSA 5206302400 manufactured by Coloplast A/s.
[16552536]
As reported to coloplast though not verified, patient was implanted with terosa saline testicular (med). Later the patient experienced the device losing fluid. An explant of the device was performed.
Patient Sequence No: 1, Text Type: D, B5
[16592409]
After further evaluation of the returned device, coloplast was unable to confirm the reported complaint. Based on the evaluation, the device performed as intended and no leaks were found. 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 | 2125050-2014-00369 |
| MDR Report Key | 3899179 |
| Report Source | 04 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-27 |
| Date of Event | 2014-04-29 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2013-05-21 |
| 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 | 1601 W 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 | TEROSA |
| Generic Name | SALINE FILLED TESTICULAR PROSTHESIS, PRODUCT CODE: FAF |
| Product Code | FAF |
| Date Received | 2014-05-29 |
| Returned To Mfg | 2014-05-02 |
| Model Number | 5206302400 |
| Catalog Number | 5206302400 |
| Lot Number | 3698615 |
| Device Expiration Date | 2018-05-20 |
| 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 | 2014-05-29 |