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

Catalog Number	501520
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Bacterial Infection (1735); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Nervous System Injury (2689); Kidney Infection (4502); Dyspareunia (4505); Pelvic Pain (4865)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed at this time.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.D10: the altis device is captured under a separate medwatch report.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced protrusion of the mesh, extrusion, excision, bleeding, infections, pelvic floor disfunction, pelvic pain, vaginal pain, dyspareunia, urinary urgency problems, scarring, difficulty with daily activities, and permanent and substantial physical deformity, which ultimately required surgical intervention and removal of mesh.
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 in veeva 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.D10: the altis device is captured under a separate medwatch report.
Event or Problem Description
As additionally reported to coloplast, though not verified, the patient also suffered complications associated with the device, including but not limited to urinary tract infection, bacterial vaginosis and yellow/gray discharge.Exploratory laparotomy with removal of eroded restorelle y.Intraoperative findings: eroded vaginal mesh across the apex of the vagina.Area of the mesh near the left side of the cuff with brownish black inflammatory exudate.Mesh was eroded into the vagina pathology: mesh (gross diagnosis): benign fibroadipose tissue with chronic inflammation, hemorrhage, and reactive changes.Specimen consisted of two segments of pink-purple mesh with attached membranous tissues (4.0 x 1.5 x 1.0 cm and 2.5 x 1.0.0.3 cm).Foreign body culture positive for gram negative rod and streptococcus anginosus group.
Event or Problem Description
As additionally reported to coloplast, though not verified, the patient also suffered complications associated with the device, including but not limited to chronic nerve damage and incomplete bladder emptying.
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 in veeva 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.D10: the altis device is captured under a separate medwatch report.

• 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: 22341630
• Report Number: 2125050-2025-01044
• Device Sequence Number: 9160165
• Product Code: OTO
• 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: 2022
• 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,Followup,Followup
• Report Date (Section B): 05/20/2026

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: 06/21/2025
• Device Catalogue Number: 501520
• Device Lot Number: 8562191_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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 01/12/2026; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2022
• 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 Sex: Unknown