Brand Name | VIRTUE |
Type of Device | MESH, SURGICAL, MALE |
Manufacturer (Section D) |
COLOPLAST A/S |
holtedam 1 |
humlebaek, 3050 |
DA 3050 |
|
Manufacturer (Section G) |
COLOPLAST MANUFACTURING US, LLC |
1601 west river road n |
|
minneapolis MN 55411 |
|
Manufacturer Contact |
leeanne
swiridow
|
1601 west river road n |
minneapolis, MN 55411
|
6123024945
|
|
MDR Report Key | 4476281 |
MDR Text Key | 20751404 |
Report Number | 2125050-2015-00023 |
Device Sequence Number | 1 |
Product Code |
OTM
|
Combination Product (y/n) | N |
PMA/PMN Number | K101297 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Study |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
01/30/2015 |
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 |
Other
|
Device Expiration Date | 10/31/2011 |
Device Model Number | 5002022400 |
Device Catalogue Number | 50020 |
Device Lot Number | 2531871 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/05/2015
|
Initial Date FDA Received | 02/02/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/31/2010 |
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Other;
|
|
|