MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS RETROARC RETROPUBIC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 9000262

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 10/14/2015

Event Type  Injury  

Event Description

It was reported that following the implantation of a retroarc, the patient experienced expected postoperative pelvic pain at all the incision areas.Percocet and ibuprofen were administered on (b)(6) 2015.The event was considered recovering/resolving (adverse event is improving).There were no further patient complications reported in relation to this event.Related to mfr # 3011770902-2015-00111.

Manufacturer Narrative

Add'l info.

Event Description

Additional information received indicated that the event was considered recovered/resolved with no sequelae on (b)(6) 2015.There were no further patient complications reported in relation to this event.

• Brand Name: AMS RETROARC RETROPUBIC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 5335014
• MDR Text Key: 34674046
• Report Number: 3011770902-2015-00112
• Device Sequence Number: 1
• Product Code: OTN
• 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: 12/29/2015

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: 05/21/2018
• Device Catalogue Number: 9000262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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
• Patient Outcome(s): Required Intervention