MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y CONTOUR; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501520
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Deformity/ Disfigurement (2360); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Fecal Incontinence (4571); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	03/08/2024
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.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.
Event or Problem Description
As reported to coloplast, though not verified: the patient had a restorelle implanted in (b)(6) 2024.Reportedly the patient experienced mesh erosion, slightly friable epithelial edges, abnormal discharge and labial irritation.Patient underwent mesh excision with defect closure, pelvic examination and cystoscopy under general anesthesia.Post excision, on exam some granulation tissue noted on left pelvic proximal side wall.Patient also reportedly experienced myofascial pain, anal/flatal sphincter incontinence and dyspareunia with deep penetration.
Event or Problem Description
As reported to coloplast, though not verified: it was additionally reported that the patient experienced pelvic and abdominal pain, lower back pain, extrusion, protrusion, urinary issues, recurrence, stress urinary incontinence, vaginal discharge, vaginal cramping, nocturia, suprapubic pressure, pain, permanent disfigurement, and difficulty with daily activities which ultimately required surgical intervention and removal of mesh on (b)(6) 2024.
Additional Manufacturer Narrative
Correction: b2.Added: disability or permanent damage.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.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.
Event or Problem Description
As reported to coloplast, though not verified: it was additionally reported that the patient experienced pelvic and abdominal pain, lower back pain, extrusion, protrusion, urinary issues, recurrence, stress urinary incontinence, vaginal discharge, vaginal cramping, nocturia, suprapubic pressure, pain, permanent disfigurement, and difficulty with daily activities which ultimately required surgical intervention and removal of mesh on (b)(6) 2024.
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.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: 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: 24115896
• Report Number: 2125050-2026-00102
• Device Sequence Number: 17627520
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 5708932528108
• 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: 2024
• 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,Followup,Followup
• Report Date (Section B): 03/24/2026

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 Expiration Date: 09/13/2026
• Device Catalogue Number: 501520
• Device Lot Number: 9214593_5015202400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 03/24/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2023
• 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; Disability
• Patient Age: 58 YR
• Patient Sex: Unknown