MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-01 for PENUMA IMPLANT manufactured by National Medical Devices Inc..
[101578523]
Dr (b)(6) claims he has a 501(k) clearing a product for a penile implant. When looking up his 510(k) #k042380. It states it's for ears nose and throat. He is using this approval to secure trust in pts. It's absolutely meaningless and extremely misleading. This product that mr (b)(6) is using is destroying the lives of many men. He is playing on them, lying on them and leaving them with a mess to deal with afterwards. My husband is pretty disfigured from his procedure, and it is interfering with daily life functions; dr (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075640 |
| MDR Report Key | 7313083 |
| Date Received | 2018-03-01 |
| Date of Report | 2018-02-28 |
| Date of Event | 2018-01-26 |
| Date Added to Maude | 2018-03-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | PENUMA IMPLANT |
| Generic Name | PENILE SILICONE BLOCK |
| Product Code | MIB |
| Date Received | 2018-03-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATIONAL MEDICAL DEVICES INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-01 |