MAUDE Adverse Event Report: COLOPLAST A/S ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number 93-4400

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

Patient Problems Pain (1994); Scar Tissue (2060); Anxiety (2328); Depression (2361); Dyspareunia (4505)

Event Type  Injury  

Event Description

According to the available information a legal summons was received indicating the following: the patient received aris sling on (b)(6) 2021.Patient reports having suffered from neuromuscular pain, dyspareunia, vulvodynia, groin pain, thigh pain, urinary issues, vaginal scarring, urethral scarring, bladder wall scarring, depression, and anxiety, as well as other symptoms and damages, including severe and permanent pain, suffering disability, impairment of mobility, impairment of sexual function, impairment of bowel and bladder function, subsequent surgical removal of mesh, loss of enjoyment of life, and economical damages.In addition, patient suffered from pre-existing injuries/conditions which were aggravated, exacerbated, and/or accelerated by implantation of aris device.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 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: 18468648
• MDR Text Key: 332372952
• Report Number: 2125050-2024-00031
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/08/2024

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: Lay User/Patient
• Device Catalogue Number: 93-4400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• 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