MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-12-31 for SALINE-FILLED TESTICULAR PROSTHESIS 5207501000 manufactured by Coloplast Manufacturing Us, Llc.
[14871861]
As reported to coloplast, a physician reported a prosthesis was damaged upon receipt, so it could not be filled just prior to implant surgery, which had to be postponed.
Patient Sequence No: 1, Text Type: D, B5
[15170127]
One testicular device was received for evaluation. Examination and testing of the device revealed a separation on the suture tab. Microscopic examination of the separation revealed a smooth and straight edge indicating sharp instrumentation was involved. Because these components were released according to manufacturing and quality control procedures, qa concluded that the observed instrument separation on the suture tab occurred subsequent to the device packaging being opened. As the device was never implanted. Qa concluded that instrument damage most likely occurred during the device prepping process prior to implant.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2008-00012 |
| MDR Report Key | 1276470 |
| Report Source | 05 |
| Date Received | 2008-12-31 |
| Date of Report | 2008-10-21 |
| Date Mfgr Received | 2008-10-21 |
| Date Added to Maude | 2009-01-23 |
| 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, MANAGER |
| Manufacturer Street | 1499 WEST 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 |
| 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 | 2008-12-31 |
| Model Number | 5207501000 |
| Catalog Number | 5207501000 |
| Lot Number | 5712686-015 |
| Device Expiration Date | 2012-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST MANUFACTURING US, LLC |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-12-31 |