MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-04-02 for AMS 700 INFLATABLE PENILE PROSTHESIS IPP 72404252 manufactured by American Medical Systems, Inc..
[21994917]
The frequency of occurrence of the event is addressed in the device labeling. The frequency for this event is not greater than is usual.
Patient Sequence No: 1, Text Type: N, H10
[22238525]
Info received on 12/14/2007 indicates a (b) (6) male with peyronie's disease and post prostatectomy was implanted with an ipp device on (b) (6) 2007. The doctor attempted to inflate the cylinders, when the cylinders did not inflate at the end of the procedure, it was due to "urethral excursion" and the cylinders were removed and the pump was plugged with the reservoir attached (deactivated and left in place). No cylinders were left in the pt. On (b) (6) 2009, pt alleged the penile implant ruptured following this surgery on (b) (6) 2007. Additional info received on 04/01/2010 indicates the pt alleges upon inserting the penile implant, doctor activated the pump to test the device to make sure it would operate. Upon activating the pump, the device ruptured and caused serious and permanent injuries, including excessive bleeding from the groin area, severe pain in the groin area, permanent disfigurement, and permanent loss of use. No further info provided at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183959-2010-00187 |
| MDR Report Key | 1650750 |
| Report Source | 99 |
| Date Received | 2010-04-02 |
| Date of Report | 2009-12-01 |
| Date of Event | 2007-11-27 |
| Date Mfgr Received | 2009-12-01 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2010-04-07 |
| 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 | CAROL SCHMOCK |
| Manufacturer Street | 10700 BREN RD., WEST |
| Manufacturer City | MINNETONKA MN 55343 |
| Manufacturer Country | US |
| Manufacturer Postal | 55343 |
| Manufacturer Phone | 9529306425 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMS 700 INFLATABLE PENILE PROSTHESIS |
| Generic Name | INFLATABLE PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2010-04-02 |
| Model Number | IPP |
| Catalog Number | 72404252 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 10700 BREN RD., WEST MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2010-04-02 |