MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-22 for PROSTHESIS, PENIS, INFLATABLE manufactured by American Medical System, Inc..
| Report Number | MW5090569 |
| MDR Report Key | 9224989 |
| Date Received | 2019-10-22 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-10-10 |
| Date Added to Maude | 2019-10-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 0 |
| Brand Name | PROSTHESIS, PENIS, INFLATABLE |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2019-10-22 |
| Returned To Mfg | 2019-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-22 |