MAUDE Adverse Event Report: ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SLING; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number UR3101

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

Patient Problems Erosion (1750); Micturition Urgency (1871); Pain (1994); Depression (2361); Urinary Incontinence (4572)

Event Date 02/01/2021

Event Type  Injury  

Event Description

According to the available information the patient could not walk and felt very heavy.A piece of the strip was removed by the gynecologist.Patient experienced incontinence, bleeding, pain and depression.

Manufacturer Narrative

The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.

• Brand Name: ARIS TRANSOBTURATOR SLING
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): ABISS - ANALYTIC BIOSURGICAL SOLUTIONS; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19117190
• MDR Text Key: 340289268
• Report Number: 2125050-2024-00589
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 05708932427999
• UDI-Public: 5708932427999
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/16/2024

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: Health Professional
• Device Expiration Date: 10/30/2017
• Device Catalogue Number: UR3101
• Device Lot Number: AM110085_UR31011022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2024
• Date Device Manufactured: 02/08/2013
• 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