Brand Name | TITAN TOUCH INFR ZERO ANG 18CM |
Type of Device | INFLATABLE PENILE PROSTHESIS |
Manufacturer (Section D) |
COLOPLAST A/S |
holtedam 1 |
humlebaek, 3050 |
DA 3050 |
|
Manufacturer (Section G) |
COLOPLAST MANUFACTURING US, LLC |
1601 west rivier road north |
|
minneapolis MN 55411 |
|
Manufacturer Contact |
sarah
o'gara
|
1601 west rivier road north |
minneapolis, MN 55411
|
6123578517
|
|
MDR Report Key | 7621163 |
MDR Text Key | 111735676 |
Report Number | 2125050-2018-00463 |
Device Sequence Number | 1 |
Product Code |
FHW
|
UDI-Device Identifier | 05708932539128 |
UDI-Public | 05708932539128 |
Combination Product (y/n) | N |
PMA/PMN Number | P000006 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial |
Report Date |
06/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | ES28182400 |
Device Catalogue Number | ES28182400 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
05/07/2018 |
Initial Date FDA Received | 06/20/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 65 YR |