MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-06-04 for SALINE-FILLED TESTICULAR PROSTHESIS 450-1327 manufactured by Coloplast Manufacturing Us, Llc.
[863064]
As reported to coloplast, the testicular lost fluid.
Patient Sequence No: 1, Text Type: D, B5
[8085239]
One testicular device was received for eval. Examination and testing of the returned component revealed no functional abnormalities. Because no functional abnormalities were observed, the cause of the reported event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2008-00001 |
| MDR Report Key | 1056478 |
| Report Source | 05,07 |
| Date Received | 2008-06-04 |
| Date of Report | 2008-05-13 |
| Date of Event | 2008-04-16 |
| Date Mfgr Received | 2008-05-13 |
| Date Added to Maude | 2008-06-11 |
| 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 | REBEKA STOLTMAN, RA MGR |
| Manufacturer Street | 1499 W. RIVER RD N. |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123024997 |
| Manufacturer G1 | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Street | 1525 WEST RIVER RD. NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55411 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SALINE-FILLED TESTICULAR PROSTHESIS |
| Generic Name | TESTICULAR PROSTHESIS |
| Product Code | FAF |
| Date Received | 2008-06-04 |
| Returned To Mfg | 2008-05-15 |
| Model Number | 450-1327 |
| Catalog Number | 450-1327 |
| Lot Number | 5715434 |
| ID Number | 5206301000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 1025137 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-06-04 |