MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-06 for AMS 700 UNK manufactured by American Medical Systems, Inc..
[15807306]
Malfunction of a penile prosthesis that has never functioned properly. Examination of both cylinders showed that they were intact. There was no leakage or breach of the outer silicone layer. With all of the fluid directed toward the reservoir, the reservoir tubing was cut and a 16-gauge angiocath was placed into the reservoir tubing. Aspiration yielded only about 9 cc of fluid indicating that the reservoir had probably not been filled at the time of the initial operation. The amount of fluid 8 cc was probably 3 to 4 cc from the pump and 3 to 4 cc of residual saline in the cylinders leftover from preparation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3527258 |
| MDR Report Key | 3527258 |
| Date Received | 2013-12-06 |
| Date of Report | 2013-11-07 |
| Date of Event | 2013-08-22 |
| Report Date | 2013-11-07 |
| Date Reported to FDA | 2013-12-06 |
| Date Reported to Mfgr | 2013-12-19 |
| Date Added to Maude | 2013-12-19 |
| 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 | 3 |
| 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 | AMS 700 |
| Generic Name | DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC |
| Product Code | JCW |
| Date Received | 2013-12-06 |
| Model Number | 700 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-06 |