PENILE PROSTHESIS Adverse Event — Malfunction (MDR 10007)
PENILE PROSTHESIS Adverse Event — Malfunction (MDR 10007) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PENILE PROSTHESIS; Generic name: PENILE PROSTHESIS; Manufacturer: AMERICAN MEDICAL SYSTEMS.
| Device | PENILE PROSTHESIS |
|---|---|
| Generic name | PENILE PROSTHESIS |
| Manufacturer | AMERICAN MEDICAL SYSTEMS |
| Report number | 10007 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 1995-03-02 |
| Narrative | SUSPECTED DEFECTIVE PROSTHESIS (PENILE) EXPLANTED ON 6/22/93INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH C |
| Source | openFDA MAUDE (device adverse events) |
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