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 Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Micturition Urgency (1871); Urinary Incontinence (4572)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, nonconforming report and capa.There were no capas that were confirmed in veeva to be associated.A nonconformance was identified as associated with this lot number; however, the failure being reported in the complaint is not related to the issue identified in the nonconformance.There were several complaints identified against this lot; however, with various failure modes.Therefore, this is not considered a trend.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 in (b)(6) 2024 which initially improved stress urinary incontinence.The patient reportedly experienced visible and palpable mesh through incision.The physician noted the sling likely dislodged during healing process from a strong cough.The patient experienced exposure of vaginal mesh, stress incontinence, urge incontinence and underwent excision of altis midurethral sling & cystoscopy.Additionally, incision & drainage of a posterior vaginal abscess/deep perineal abscess under general anesthesia was performed but not related to altis.

• 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: 25625661
• Report Number: 2125050-2026-01120
• Device Sequence Number: 21105664
• 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: 2025
• 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): 06/25/2026

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
• Device Lot Number: 9510795_5196502400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2024
• 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: 40 YR
• Patient Sex: Unknown