MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-08-19 for SALINE-FILLED TESTICULAR PROSTHESIS 5206301400 manufactured by Coloplast Manufacturing Us Llc.
[1108962]
As reported to coloplast, a patient experienced leakage in the testicular implant.
Patient Sequence No: 1, Text Type: D, B5
[8350664]
Evaluation results are pending. A follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[17060864]
As reported to coloplast, a patient experienced leakage in the testicular implant.
Patient Sequence No: 1, Text Type: D, B5
[17320649]
One testicular device was returned for evaluation. Examination and testing of the returned component revealed no functional abnormalities. Because no functional abnormalities were observed, coloplast cannot determine the cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2009-00015 |
| MDR Report Key | 1441845 |
| Report Source | 05,07 |
| Date Received | 2009-08-19 |
| Date of Report | 2009-07-23 |
| Date of Event | 2009-05-19 |
| Date Mfgr Received | 2009-07-23 |
| Date Added to Maude | 2009-08-31 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | REBEKA STOLTMAN |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 9524579228 |
| 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 | SALINE-FILLED TESTICULAR PROSTHESIS |
| Generic Name | TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2009-08-19 |
| Returned To Mfg | 2009-07-20 |
| Model Number | 5206301400 |
| Catalog Number | 5206301400 |
| Lot Number | 1743726 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US LLC |
| Manufacturer Address | 1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-08-19 |