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	Adhesion(s) (1695); Fever (1858); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Muscle Weakness/Atrophy (1967); Neuropathy (1983); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Chills (2191); Anxiety (2328); Depression (2361); Numbness (2415); Prolapse (2475); Ambulation or Postural Difficulties (2544); Intermenstrual Bleeding (2665); Neuralgia (4413); Tactile Disorders (4419); Hyperesthesia (4420); Paresthesia (4421); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Hypokalemia (4825); Pelvic Pain (4865); Complex regional pain syndrome (4899); Atrophy (4913)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient had an aris and a tutoplast implanted in (b)(6) 2020.Reportedly the patient experienced post-operative pain [prior history of sacro-iliac (si) joint problems], left sciatic pain, pelvic pain and radicular pain with paraesthesia and weakness.Mri showed significant disc involvement which correlated with her symptoms.Patient also experienced perineal pain, neurapraxia, vaginal spotting/ bleeding with odor, chills, fever, back spasms, hyperesthesia in the left leg and difficulties with daily activities due to pain.Physical therapy reportedly exacerbated the symptoms.Dyspareunia, mixed urinary incontinence, pain replication with palpation of the midurethral foreign body.The patient underwent steroid and trigger point injections.Cystocele, rectocele, dyspareunia, urgency, urinary tract infection, chronic pelvic pain and voiding dysfunction.Patient underwent explant of exposed aris sling, urethrolysis and cystoscopy under general anesthesia in (b)(6) 2021.Specimen was a 4.8 x 3.5 x 1.2 cm aggregate of two brown-gray firm, ragged and disrupted portions of mesh partially surfaced with soft tissue and muscle with adhesions.Post explant si joint difficulties, numbness and tingling still present, some urinary leakage, vaginal pain, leg paraesthesia, bilateral legs pain.Tight pelvic floor muscles on exam with symptomatic relief noted after vaginal trigger point injections given in office claimant has not been able to return to work because of the pain.She cannot sit longer than 8 minutes at a time and this prevents her from being able to drive distances as well.Urge incontinence of urine, complex regional pain syndrome, type ii, lower limb, obturator neuralgia, pudendal neuralgia (disorder), spastic pelvic floor syndrome.Patient underwent bilateral pudendal nerve block, botox injection to pelvic floor muscles, bilateral removal of groin mesh under general anesthesia in (b)(6) 2021.Dense scar tissue with embedded piece of polypropylene was identified in the right adductor muscle fibers, dense scar tissue was noted on the left with visible fibers of polypropylene identified.Spasm was noted.Blood loss: 300 ml.Hypotension and hypokalemia post-operatively.Continued numbness, spasm and pain impacting daily activities.
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 in veeva to be associated.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.
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 and/or ifu excluding ambulatory difficulties, prolapse, hypokalemia and hypotension.In this case ambulation difficulties appear to be a secondary/ subsequent effect of pain.There is no clinical evidence or data to support a causal relationship between these adverse events and aris.No further action or corrective action is required at this time.H6 health effect - clinical code corrections.Coding for prolapse, hypokalemia and hypotension removed.
Event or Problem Description
As additionally reported to coloplast, though not verified: the patient also experienced generalized anxiety disorder and depression associated with catastrophic nerve injury/ surgery and pain, bilateral obturator neuropathy, overactive bladder and vaginal atrophy.The patient states it has taken two years to recover from the mesh revision and that she has been back to work for one year.Reportedly, urinary incontinence worsened since mesh removal and there is possible cystocele.Symptoms suggest a mix of overactive bladder and possible urethral prolapse.Chronic postoperative obturator neuralgia and chronic regional pain syndrome.Pain exacerbated by stress and activities.
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, 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 and/or ifu excluding anxiety, depression, ambulatory difficulties, prolapse, hypokalemia and hypotension.There is no clinical evidence or data to support a direct causal relationship between these aes and aris.In this case ambulation difficulties and anxiety/ depression appear to be a secondary/ subsequent effect of pain and painful injuries.No further action or corrective action is required at this time.

• 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: 24284371
• Report Number: 2125050-2026-00215
• Device Sequence Number: 17612699
• 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: 2020
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 04/03/2026

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: 09/30/2022
• Device Catalogue Number: 93-4400
• Device Lot Number: 6136140_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
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/06/2026; 03/23/2026; 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AXIS TUTOPLAST PROCESSED DERMIS.; AXIS TUTOPLAST PROCESSED DERMIS.; AXIS TUTOPLAST PROCESSED DERMIS.; AXIS TUTOPLAST PROCESSED DERMIS.
• Outcome Attributed to Adverse Event: Required Intervention; Other; Disability
• Patient Age: 66 YR
• Patient Sex: Unknown