Brand Name | ALTIS SINGLE INCISION SLING SYSTEM |
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 west river road north |
|
minneapolis, mn |
|
Manufacturer Contact |
stephanie
perryman
|
1601 west river road north |
minneapolis, mn
|
|
MDR Report Key | 10186211 |
MDR Text Key | 196151819 |
Report Number | 2125050-2020-00454 |
Device Sequence Number | 1 |
Product Code |
PAH
|
Combination Product (y/n) | N |
PMA/PMN Number | K121562 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial |
Report Date |
06/19/2020 |
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
|
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
05/29/2020
|
Initial Date FDA Received | 06/23/2020 |
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 |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Other;
Required Intervention;
|