MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number	519650
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: on or about (b)(6), 2020, patient underwent a surgical procedure to treat her stress urinary incontinence and vaginal prolapse, during which her physician implanted the coloplast altis mini single incision sling mesh and coloplast restorelley-mesh into the patient.Patient subsequently suffered complications associated with the pelvic mesh products, including but not limited to, pelvic pain, protrusion, extrusion, erosion, urinary issues, urinary incontinence, recurrence, bleeding, dyspareunia, heavy discharge, vaginal scarring, infections, permanent disfigurement, exposure of the mesh to surrounding tissue/organs, and difficulty with daily activities.On or around (b)(6), 2024, patient underwent vaginal mesh excision.On or around (b)(6), 2025, patient underwent vaginal mesh removal surgery.Patient has suffered, and continues to suffer, multiple, severe, and painful personal injuries, including, but not limited to, erosion, bleeding, protrusion, extrusion, vaginal and pelvic pain, dyspareunia, urinary urgency and incontinence issues, scarring, permanent physical deformity, and difficulty with daily activities, which she will continue to suffer for the rest of her life.This report captures the altis device.
Additional Manufacturer Narrative
B3: date of event not known.Best estimate not provided as year not known.D10: restorelle polypropylene mesh for sacrocolpopexy, sacrocervicopexy, and sacrohysteropexy.As no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.The device was not returned for evaluation.Without the benefit of analyzing the device, quality 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.

• Brand Name: ALTIS SINGLE INCISION SLING SYSTEM
• Common Device Name: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• 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: 25458941
• Report Number: 2125050-2026-00971
• Device Sequence Number: 10450367
• Product Code: PAH
• UDI-Device Identifier: 05708932467407
• UDI-Public: 5708932467407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 519650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: RESTORELLE
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Unknown