MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720046-01

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

Patient Problem Irritation (1941)

Event Date 03/24/2015

Event Type  Injury  

Event Description

(b)(4).It was reported that following the implantation of a miniarc sling, the patient experienced urethral irritation.The patient went to the emergency room with possible urinary retention.The post void residual testing did not show any urine."a foley catheter was placed & drained 125ml initially & 75ml over next hr." the patient diagnosis was "urethral irritation from dehydration and recent instrumentation.No retention diagnosis".The event was considered resolved/recovered with no sequelae on (b)(6) 2015.There were no further patient complications reported as a result of this event.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4655791
• MDR Text Key: 20720722
• Report Number: 2183959-2015-00133
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/25/2015

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: 12/02/2017
• Device Catalogue Number: 720046-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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: ELEVATE ANTERIOR
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR