MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-07-22 for SALINE-FILLED TESTICULAR PROSTHESIS 5206301400 manufactured by Coloplast Manufacturing Us Llc.
[18083601]
One testicular device was received for evaluation. Evaluation and testing of the returned component revealed a separation between the midline and the injection port on the shell of the device. Testing revealed this to be the site of leakage. Microscopic examination of the surfaces revealed them to be smooth, indicating contact with sharp instrumentation. This component was released according to manufacturing and quality control procedures; thus, coloplast concludes that the observed instrument damage on the testicular shell occurred subsequent to the device packaging being opened. Because the limited information provided to coloplast does not indicate any factors that may have contributed to the reported event, coloplast cannot determine or comment on the sequence of events resulting in the observed separation.
Patient Sequence No: 1, Text Type: N, H10
[18372109]
As reported to coloplast, a patient experienced leakage in the testicular device from a hole in the device.
Patient Sequence No: 1, Text Type: D, B5
[20615838]
As reported to coloplast, a patient experienced leakage in the testicular device from a hole in the device.
Patient Sequence No: 1, Text Type: D, B5
[20832422]
Evaluation results are pending. A follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2009-00012 |
| MDR Report Key | 1417971 |
| Report Source | 05,07 |
| Date Received | 2009-07-22 |
| Date of Report | 2009-06-24 |
| Date of Event | 2008-12-01 |
| Date Mfgr Received | 2009-06-24 |
| Date Added to Maude | 2009-08-24 |
| 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 | 6123024997 |
| 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 | 2009-07-22 |
| Model Number | 5206301400 |
| Catalog Number | 5206301400 |
| Lot Number | 1743726 |
| Operator | PHYSICIAN |
| 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 | 1601 WEST RIVER ROAD NORTH MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-22 |