MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for AMS PRECONNECT (21CM) 72404233-12 manufactured by American Medical System, Inc..
[176622837]
Penile implant malfunctioned. Pt required another surgery to replace. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092512 |
| MDR Report Key | 9632334 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-14 |
| Date Added to Maude | 2020-01-27 |
| 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 |
| 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 PRECONNECT (21CM) |
| Generic Name | PROSTHESIS, PENIS, INFLATABLE |
| Product Code | JCW |
| Date Received | 2020-01-24 |
| Model Number | 72404233-12 |
| Lot Number | 1000218384 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICAN MEDICAL SYSTEM, INC. |
| Manufacturer Address | MINNETONKA MN 55343 US 55343 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-24 |