Brand Name | TITAN INFLATABLE PENILE PROSTHESIS FAMILY |
Type of Device | PENILE PROSTHESIS, INFLATABLE |
Manufacturer (Section D) |
COLOPLAST A/S |
1 holtedam humlebaek, dk 3050 |
humlebaek 3050 |
DA 3050 |
|
Manufacturer Contact |
usbes
brian schmidt
|
1601 west river road n |
minneapolis, MN 55411
|
|
MDR Report Key | 18739193 |
MDR Text Key | 335756875 |
Report Number | 2125050-2024-00278 |
Device Sequence Number | 1 |
Product Code |
FHW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P000006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/20/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/20/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | ES2822 |
Is the Reporter a Health Professional? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 57 YR |
Patient Sex | Male |
|
|