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

Catalog Number	93-4400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Anxiety (2328); Depression (2361); Numbness (2415); Ambulation or Postural Difficulties (2544); Constipation (3274); Neuralgia (4413); Suicidal Ideation (4429); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Interstitial Cystitis (4862); Pelvic Pain (4865)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, non-conformances and capas could not be complete.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast cannot comment on the condition of the device.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
As reported to coloplast, though not verified: on (b)(6) 2023 the patient was implanted with an aris device.The physician implanted the aris properly and appropriately.Following implantation of aris, patient began experiencing pelvic pain, pelvic floor tightness, and vaginal pain.She was subsequently diagnosed with pudendal neuralgia and is receiving ongoing medical treatment for her injuries.Her future prognosis is unknown.Patient has also suffered and in all reasonable probability will continue to suffer 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 the mesh, loss of enjoyment of life, and economic damages.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the nature of this complaint and the device not being returned for evaluation, a thorough investigation could not be executed.Should additional information become available, a follow-up report will be submitted.Complaints of this nature are monitored and captured within the product risk documentation excluding emotional changes, and ambulation or postural difficulties.There is no direct causal relationship between these ae's and aris.No further action or corrective action is required at this time.
Event or Problem Description
As additionally reported to coloplast though not verified: the patient also experienced abdominal pain, acute nonlocalized rectal pain, constipation, mesh erosion, cystitis and pudendal neuropathy.
Additional 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 to be associated.
Event or Problem Description
As additionally reported though not verified, the patient had pelvic pain since mesh placement and was hospitalized for suicidal ideations due to pain.The patient also experienced urinary tract infections.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation excluding emotional changes, ambulation or postural difficulties, and constipation.There is no direct causal relationship between these aes and aris.No further action or corrective action is required at this time.
Additional Manufacturer Narrative
B3: date of event updated.
Event or Problem Description
As additionally reported to coloplast, though not verified: the patient has also experienced pain and numbness in vaginal area, tingling near urethra, urinary retention, inflammation, voiding dysfunction, myofascial pain syndrome and stress urinary incontinence.The patient underwent a psychiatric hospital admission in (b)(6) 2023 for suicidal ideation due to anxiety/depression and frustration with severe pain.The patient has also received catheterization for inability to void, fluoroscopy guided bilateral pudendal nerve blocks, implant of peripheral nerve stimulator for pudendal nerves and multiple pudendal nerve injections and further nerve block providing short term pain relief.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23637440
• Report Number: 2125050-2025-01839
• Device Sequence Number: 10011304
• Product Code: OTN
• UDI-Device Identifier: 05708932442961
• UDI-Public: 5708932442961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050148
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/12/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 93-4400
• Device Lot Number: 8941495_5195512400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/05/2025; 04/08/2026; 05/12/2026; 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Unknown