MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-21 for TOROSA * 450-1329 manufactured by Coloplast Corporation.
[3817350]
The night prior to the surgery the physician reviewed the you-tube video to refresh his knowledge on use and filling of the prosthetic implant. On the day of surgery the first implant was filled and was found to have a leak. The second prosthesis was filled and was also found to have a leak. As only two implants were available within the local area, the patient was closed without the implant. Upon review of the case it was found that while the you-tube video opens with a screen discussing use of a needle stop, the video itself does not show the needle stop in use during any part of the video. It was also discovered that the needle stops are not identified inside the packaging. The manual that comes with the package makes a reference to the needle stop on page 7 but does not have any details on what it looks like.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3352294 |
| MDR Report Key | 3352294 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-08-21 |
| Report Date | 2013-08-21 |
| Date Reported to FDA | 2013-08-21 |
| Date Reported to Mfgr | 2013-09-17 |
| Date Added to Maude | 2013-09-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOROSA |
| Generic Name | PROSTHESIS, TESTICULAR |
| Product Code | FAF |
| Date Received | 2013-08-21 |
| Model Number | * |
| Catalog Number | 450-1329 |
| Lot Number | 3660017 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 0 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLOPLAST CORPORATION |
| Manufacturer Address | 1601 WEST RIVER ROAD MINNEAPOLIS MN 55411 US 55411 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-21 |