MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-02-13 for SALINE FILLED TESTICULAR PROSTHESIS 450-1327 manufactured by Coloplast Manufacturing Us Llc.
[19284205]
Date of event: (b)(6)2009. According to the available information, this saline testicular device was to be implanted on (b)(6)2009 but was not due to device had a hole in it when opened. Additional information received from the territory manager who was present at the surgery, indicated upon filling the device, saline began to shoot out through what appeared to be a small hole. Surgeon claims he did not puncture the implant with the needle and tm did not witness him do so. Surgery was not delayed as tm had a second device of the appropriate size in the operating room.
Patient Sequence No: 1, Text Type: D, B5
[19514340]
One testicular device was received for evaluation. Evaluation and testing of the returned component revealed a separation between the mid line and injection port on the shell of the device. Testing revealed this to be the site of leakage. Microscopic examination revealed the surface of the separation to have a central groove indicating that area was in contact with a small sharp instrument such as a needle. Because this component was released according to manufacturing and quality control procedures, qa concluded that the observed instrument damage on the testicular shell occured subsequent to the device packaging being opened. As the device was never implanted, qa concluded that instrument damage most likely occurred during the prepping procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2125050-2010-00004 |
| MDR Report Key | 1598916 |
| Report Source | 07 |
| Date Received | 2010-02-13 |
| Date of Report | 2009-12-09 |
| Date of Event | 2009-11-06 |
| Date Mfgr Received | 2009-12-09 |
| Date Added to Maude | 2010-06-01 |
| 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 | MR. BRIAN SCHMIDT |
| Manufacturer Street | 1601 WEST RIVER ROAD NORTH |
| Manufacturer City | MINNEAPOLIS MN 55411 |
| Manufacturer Country | US |
| Manufacturer Postal | 55411 |
| Manufacturer Phone | 6123054987 |
| 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 | 2010-02-13 |
| Model Number | 450-1327 |
| Catalog Number | 450-1327 |
| Lot Number | 5720929 |
| ID Number | 5206301000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2010-02-13 |