MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-09 for TOROSA SALINE TESTICULAR MED 5206302400 manufactured by Coloplast A/s.
[107786873]
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence. Once our evaluation is complete, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[107786874]
According to the available information, implant was migrating, had been tied down at surgery and once incision was made, implant surface. The tied down tab was broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2125050-2018-00360 |
| MDR Report Key | 7500406 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-09 |
| Date of Report | 2018-07-10 |
| Date of Event | 2018-04-10 |
| Date Mfgr Received | 2018-04-11 |
| Date Added to Maude | 2018-05-09 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE PERRYMAN |
| Manufacturer Street | 1601 WEST RIVIER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6124345685 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1601 WEST RIVIER 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 SALINE TESTICULAR MED |
| Generic Name | SALINE FILLED TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2018-05-09 |
| Returned To Mfg | 2018-05-02 |
| Model Number | 5206302400 |
| Catalog Number | 5206302400 |
| Lot Number | 4083537 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2018-05-09 |