MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH

Catalog Number 720127-01

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dysuria (2684)

Event Date 01/19/2016

Event Type  Injury  

Event Description

It was reported that following the implantation of an elevate posterior, the patient experienced difficulty emptying bladder.The patient was discharged home from the hospital with a foley catheter for a post-void residual (pvr) of 450cc.The patient had another voiding trial and the foley catheter was backfilled with 360cc sterile water, then was removed.The patient voided 250cc.The event was considered recovered/resolved with sequelae on (b)(6) 2016.There were no further patient complications reported in relation to this event.Related to mfr # 3011770902-2016-00051.

• Brand Name: AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
• Type of Device: SURGICAL MESH
• 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 ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5396898
• MDR Text Key: 37037803
• Report Number: 3011770902-2016-00050
• Device Sequence Number: 1
• Product Code: OTP
• 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
• Report Date: 01/22/2016

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: 09/15/2018
• Device Catalogue Number: 720127-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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: MINIARC PRO
• Patient Outcome(s): Required Intervention