MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-07 for AMS AMBICOR PENILE PROSTHESIS 72401451 manufactured by Boston Scientific.
[99607023]
Penile implant placed (b)(6) 2016, device was explanted on (b)(6) 2018 due to mechanical complication of prosthetic device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075116 |
| MDR Report Key | 7250950 |
| Date Received | 2018-02-07 |
| Date of Report | 2018-02-06 |
| Date of Event | 2018-02-05 |
| Date Added to Maude | 2018-02-08 |
| 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 | 0 |
| Brand Name | AMS AMBICOR PENILE PROSTHESIS |
| Generic Name | AMS AMBICOR PENILE PROSTHESIS |
| Product Code | JCW |
| Date Received | 2018-02-07 |
| Returned To Mfg | 2018-02-06 |
| Model Number | 72401451 |
| Lot Number | 120453005 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-07 |