Brand Name | AMS MINIARC PRECISE SINGLE-INCISION SLING |
Type of Device | MESH, SURGICAL, POLYMERIC |
Manufacturer (Section D) |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 bren rd w |
minnetonka MN 55343 |
|
Manufacturer (Section G) |
AMERICAN MEDICAL SYSTEMS, INC. |
10700 bren rd w |
|
minnetonka MN 55343 |
|
Manufacturer Contact |
erika
merrick
|
10700 bren rd w |
minnetonka, MN 55343
|
8442511068
|
|
MDR Report Key | 5146725 |
MDR Text Key | 28141604 |
Report Number | 2183959-2015-57069 |
Device Sequence Number | 1 |
Product Code |
PAH
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,other |
Reporter Occupation |
Attorney
|
Report Date |
07/07/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/14/2015 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 02/14/2015 |
Device Catalogue Number | 720191-01 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 07/07/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/13/2012 |
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 |
Treatment | ELEVATE POSTERIOR |
Patient Outcome(s) |
Disability;
|
|
|