MAUDE Adverse Event Report: Coloplast A/S Restorelle Y Contour; Pelvic organ prolapse surgical mesh, synthetic polymer

Catalog Number	501520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Pain (1994); Renal Failure (2041); Vomiting (2144); Electrolyte Imbalance (2196); Deformity/ Disfigurement (2360); Obstruction/Occlusion (2422); Fluid Discharge (2686); Dyspareunia (4505); Urinary Incontinence (4572); Biliary Leak (4820); Hypokalemia (4825); Pelvic Pain (4865); Abnormal scarring (4896)
Date of Event	08/21/2023
Type of Reportable Event	Serious Injury
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.The device was not returned for evaluation.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 with this device experienced nausea, vomiting, acute kidney injury, small bowel obstruction caused by mesh adhesion to uterine and small bowel, acute renal failure with tubular necrosis due to post-op small bowel obstruction, significant bile effluent from ng "[nasogastric]", high output from ng, hypokalemia and hypophosphatemia.Laparoscopic removal of mesh was performed.
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 a supplemental report will be filed.Complaints of this nature are monitored and captured within the product risk documentation except nausea, vomiting, dehydration, renal failure, biliary leak, and (hypokalemia) electrolyte imbalance.There are no literature data to support direct causal relationship between restorelle and nausea, vomiting, dehydration, renal failure, biliary leak, and (hypokalemia)electrolyte imbalance.However, they appear to be secondary or cascading effects of occlusion (the primary harm).No further action or corrective action is required at this time.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device additionally experienced pelvic and abdominal pain, mesh to bowel, urinary issues, recurrence, bleeding, dyspareunia, vaginal scarring, permanent disfigurement and emotional pain.The patient has, will, or may suffer apprehension of increased risk for injuries, infections, pain, mental anguish, discharge, and potentially additional removal and/or corrective surgeries as a result of implantation of the mesh.

• Brand Name: Restorelle Y Contour
• Common Device Name: Pelvic organ prolapse surgical mesh, 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: 22285492
• Report Number: 2125050-2025-00996
• Device Sequence Number: 18213328
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123914
• 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
• Report Date (Section B): 08/06/2026

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: 11/02/2025
• Device Catalogue Number: 501520
• Device Lot Number: 8809736_5015202400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 07/28/2026
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/25/2025; 09/03/2025; 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2022
• 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: 68 YR
• Patient Sex: Female