Brand Name | AMS MONARC SLING SYSTEM |
Manufacturer (Section D) |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 bren road west |
minnetonka MN 55343 |
|
Manufacturer Contact |
sharon
zurn, dir, qual compl
|
10700 bren road west |
minnetonka, MN 55343
|
9529306347
|
|
MDR Report Key | 4377571 |
MDR Text Key | 18065558 |
Report Number | 2183959-2014-22336 |
Device Sequence Number | 1 |
Product Code |
OTN
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K023516 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Consumer |
Reporter Occupation |
Not Applicable
|
Type of Report
| Initial |
Report Date |
04/07/2014 |
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? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 02/12/2008 |
Device Catalogue Number | 72403830 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/07/2014
|
Initial Date FDA Received | 12/30/2014 |
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 |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|