Brand Name | VIRTUE MALE SLING SYSTEM WITH ALEXIS |
Type of Device | SURGICAL MESH |
Manufacturer (Section D) |
COLOPLAST A/S |
holtedam-1 |
humlebaek, 3050 |
DA 3050 |
|
Manufacturer (Section G) |
COLOPLAST MANUFACTURING US, LLC |
1601 w. river road n |
|
minneapolis MN 55411 |
|
Manufacturer Contact |
tim
crabtree-ra manager
|
1601 w. river road n |
minneapolis, MN 55411
|
6123024922
|
|
MDR Report Key | 3660819 |
MDR Text Key | 18567429 |
Report Number | 2125050-2014-00157 |
Device Sequence Number | 1 |
Product Code |
OTM
|
Combination Product (y/n) | N |
PMA/PMN Number | K111881 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/26/2014 |
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 |
Physician
|
Device Expiration Date | 08/31/2014 |
Device Model Number | 5002041400 |
Device Catalogue Number | 5002041400 |
Device Lot Number | 359920 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/28/2014 |
Initial Date FDA Received | 03/05/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|