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 | 18238290 |
MDR Text Key | 329380452 |
Report Number | 2125050-2023-01504 |
Device Sequence Number | 1 |
Product Code |
FHW
|
UDI-Device Identifier | 05708932539135 |
UDI-Public | 05708932539135 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
PMA/PMN Number | P000006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
11/30/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/30/2023 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | ES2820 |
Device Lot Number | 7569063_ES28201022 |
Date Device Manufactured | 08/13/2020 |
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 Sex | Male |