Brand Name | GENESIS MALLEABLE |
Type of Device | INFLATABLE PENILE PROSTHESIS |
Manufacturer (Section D) |
COLOPLAST A/S |
holtedam 1 |
humlebæk 3050 |
DA 3050 |
|
Manufacturer (Section G) |
COLOPLAST MANUFACTURING US, LLC |
1940 commerce dr |
|
north mankato |
|
Manufacturer Contact |
usaby
angela kilian
|
1601 west river road north |
minneapolis, MN 55411
|
8007880293
|
|
MDR Report Key | 12291522 |
MDR Text Key | 265555843 |
Report Number | 2125050-2021-01107 |
Device Sequence Number | 1 |
Product Code |
FAE
|
UDI-Device Identifier | 05708932324748 |
UDI-Public | 05708932324748 |
Combination Product (y/n) | N |
PMA/PMN Number | , K040959 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
08/06/2021 |
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 |
Health Professional
|
Device Model Number | 5192601400 |
Device Catalogue Number | 519260 |
Device Lot Number | 7433701 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/23/2021
|
Initial Date FDA Received | 08/06/2021 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/20/2020 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 49 YR |
|
|