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

Catalog Number 93-4400

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Fistula (1862); Pain (1994); Intermenstrual Bleeding (2665); Dyspareunia (4505)

Event Type  Injury  

Event Description

According to the available information the device was explanted due to the patient experiencing severe pain, mesh erosion and exposure/extrusion/protrusion.

Event Description

Additional information received on 1/15/2024 provides the following patient symptoms: vaginal fistula formation, vaginal bleeding and dyspareunia.

• 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: 18209974
• MDR Text Key: 329023495
• Report Number: 2125050-2023-01462
• 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,Followup
• Report Date: 01/29/2024

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: 01/15/2013
• Device Catalogue Number: 93-4400
• Device Lot Number: 5723699_5195501000
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2024
• Date Device Manufactured: 01/17/2008
• 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
• Patient Age: 52 YR