MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-31 for PENILE INSERTION DEVICE manufactured by Ama - Coloplast Corp..
[59048125]
Reporter stated that his device malfunctioned and is causing him a lot of pain. Reporter states that he is running out of money and unable to get the device explanted since he has had to pay for this device three times. He has been, and is still in pain and very frustrated as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065745 |
| MDR Report Key | 6072149 |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-31 |
| Date of Event | 2011-01-01 |
| Date Added to Maude | 2016-11-02 |
| 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 | PATIENT |
| 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 | PENILE INSERTION DEVICE |
| Generic Name | PENILE INSERTION DEVICE |
| Product Code | LKY |
| Date Received | 2016-10-31 |
| ID Number | M1786N |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMA - COLOPLAST CORP. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |