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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.No capas that were confirmed in veeva to be associated.Ncs were identified as associated with this lot number; however, the failure being reported in the complaint (various aes) is not related to the issue identified in the nc (dynamic anchor separation).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, the patient had an altis device implanted and experienced the following: pelvic pressure, constipation, shortness of breath with exertion, burning and muscle twitching at incision sites, small amount of granulation tissue in right corner of vaginal cuff, vaginal odor, vaginal pain, abdominal pain and cramping, erosion and exposure, tenderness on palpation, pain with sitting, dyspareunia, dysuria, aching in legs and hips, urinary frequency and nocturia.In (b)(6) 2025, patient underwent vaginal mesh excision and cystourethroscopy under general anesthesia.1 cm sling erosion along the left paravaginal sulcus at the 3 o¿clock position was excised.Reportedly the patient experienced muscle tightness in pelvis, dyspareunia, further mesh exposure just distal to urethral meatus, which was painful on palpation, poking sensation, vaginal burning, pain with sitting, stress urinary incontinence and being sexually inactive due to pain.In (b)(6) 2026, patient underwent removal of synthetic stress incontinence sling, cystourethroscopy exam under anesthesia and periurethral injection of bulkamid.Patient had acute urinary retention post-op.

• 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: 25446888
• Report Number: 2125050-2026-00958
• Device Sequence Number: 9613940
• 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: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2026

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 Catalogue Number: 519650
• Device Lot Number: 9544836_5196502400
• 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
• Initial Report FDA Received Date: 06/09/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2024
• 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: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Unknown