Brand Name | PROSTHESIS, PENILE |
Type of Device | PROSTHESIS, PENILE |
Manufacturer (Section D) |
COLOPLAST MANUFACTURING US, LLC. |
|
|
MDR Report Key | 19193904 |
MDR Text Key | 341316217 |
Report Number | MW5154357 |
Device Sequence Number | 1 |
Product Code |
FAE
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Unknown
|
Type of Report
| Initial |
Report Date |
04/10/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | TITAN |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/25/2024 |
Patient Sequence Number | 1 |
|
|