MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-14 for AMS 700 72402960 manufactured by American Medical Systems, Llc.
[62366248]
Patient Sequence No: 1, Text Type: N, H10
[62366249]
Patient was taken to surgery for replacement of a malfunctioning inflatable penile prosthesis that was placed at this hospital 10 years ago. Patient reported fluid loss pre-operatively. Surgeon noted that device had worked well until recently when patient noticed lost fluid. During the replacement surgery, surgeon noted that due to patient's obesity, the tubing tore and the reservoir was left in situ. There was space for the fluid reservoir and placed a low profile 100 ml inhibizone covered reservoir in this cavity. An 18 cm pre-connected cylinders with 5 cm rear-tip extenders were placed in each corporal body. There were no post-op complications and the patient was discharged to home the day after surgery. Ams worksheet lists the penile prosthesis as ams 700 tactile pump. The previous surgery lists the following implanted devices: ams 700(tm) reservoir, iz ref 72402960, lot # 433758004; volume 100 ml. Ams 700(tm) accessory kit, ref 72401850, lot # 441323006. Ams 700 cx(tm) preconnect, iz, ref 72403965, lot # 438038007; 18 cm x 12 mm. Manufacturer response for inflatable penile prosthesis, ams 700 tm (per site reporter): manufacturer will evaluate the device when it is returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6173669 |
| MDR Report Key | 6173669 |
| Date Received | 2016-12-14 |
| Date of Report | 2016-10-19 |
| Date of Event | 2016-10-11 |
| Report Date | 2016-10-19 |
| Date Reported to FDA | 2016-10-19 |
| Date Reported to Mfgr | 2016-10-19 |
| Date Added to Maude | 2016-12-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2016-12-14 |
| Model Number | AMS 700 |
| Catalog Number | 72402960 |
| Lot Number | 433758004 |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, LLC |
| Manufacturer Address | 10700 BREN ROAD WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-14 |