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

Device Problem Separation Failure (2547)

Patient Problem Urinary Retention (2119)

Event Date 12/03/2015

Event Type  Injury  

Event Description

It was reported that during the implant of a monarc, the physician had difficulty removing the plastic sheath from the sling.It would not separate at the mid-line area and he had to use extreme force to break the plastic.The physician felt that by pulling on the mesh so much, it was over tensioned, and it was "much tighter than he would usually accept" despite using a "hagar" behind the sling.The patient was in retention post-operatively and had residuals of 150 ml's of urine.After failing another trial of void, the physician took the patient back into surgery and cut the sling at the mid-line.The patient was able to void, but still had residual urine.As of (b)(6) 2015, the patient had passed a trial of void post-revision and was recovering.No further patient complications were reported in relation to this event.

• Brand Name: AMS MONARC 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 LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5341624
• MDR Text Key: 34974812
• Report Number: 3011770902-2016-00004
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2015

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2015
• Initial Date FDA Received: 01/04/2016
• 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): Required Intervention