MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-08-27 for SALINE-FILLED TESTICULAR PROSTHESIS 450-1327 manufactured by Coloplast Manufacturing Us, Llc.
[15608784]
As reported to coloplast, the testicular malfunctioned and was defective, due to leakage.
Patient Sequence No: 1, Text Type: D, B5
[15989095]
One testicular device was received for evaluation. Examination and testing of the returned component revealed a separation between portions of the shell of the device. Microscopic examination of the surfaces revealed a central groove indicating contact with sharp instrumentation such as a needle. Because these components were released according to manufacturing and quality control procedures, it is concluded that the observed instrument separation on the shell occurred subsequent to the device packaging being opened. As the device was never implanted, it is concluded that the instrument damage likely occurred during the filling process prior to implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2008-00006 |
| MDR Report Key | 1136893 |
| Report Source | 05 |
| Date Received | 2008-08-27 |
| Date of Report | 2008-06-23 |
| Date of Event | 2008-06-05 |
| Date Mfgr Received | 2008-06-23 |
| Date Added to Maude | 2008-09-03 |
| 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, MANAGER |
| Manufacturer Street | 1499 WEST RIVER RD. NORTH |
| 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 | 2008-08-27 |
| Returned To Mfg | 2008-06-23 |
| Model Number | 450-1327 |
| Catalog Number | 450-1327 |
| Lot Number | 5723251 |
| 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 | 1153099 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-08-27 |