Brand Name | AMS MINIARC PRO SINGLE INCISION SLING SYSTEM |
Type of Device | MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, MINI-SLING |
Manufacturer (Section D) |
ASTORA WOMEN'S HEALTH LLC |
13200 pioneer trail |
suite 100 |
eden prairie MN 55347 |
|
Manufacturer (Section G) |
ASTORA WOMEN'S HEALTH (IRELAND) |
athlone business & tech park |
garrycastle, dublin road |
co. westmeath MN |
EI
|
|
Manufacturer Contact |
erika a.
merrick
|
13200 pioneer trail |
suite 100 |
eden prairie, MN 55347
|
9522383906
|
|
MDR Report Key | 5315197 |
MDR Text Key | 34006725 |
Report Number | 3011770902-2015-00076 |
Device Sequence Number | 1 |
Product Code |
PAH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
12/14/2015 |
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 |
Lay User/Patient
|
Device Expiration Date | 09/29/2018 |
Device Catalogue Number | 9000261 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/14/2015
|
Initial Date FDA Received | 12/21/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 12/28/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/16/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|