MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE POLYPROPYLENE MESH FOR SACROCOLPOPEXY, SACROCERVICOPEXY, AND SACROHYS; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501420
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Prolapse (2475); Intermenstrual Bleeding (2665); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient had a restorelle y implanted in (b)(6) 2021.Reportedly the patient experienced vaginal bleeding, passing of large clots and was admitted to hospital.Ct abdomen/pelvis ¿ was performed and identified a small amount of complex fluid in vaginal vault likely representing blood products, otherwise normal.On exam eroded area at vaginal apex in which mesh is exposed, area bleeds easily when touched.Outpatient excision of extruded mesh proposed.No confirmation of excision being performed at this time.
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 remains implanted.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the 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 updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.
Event or Problem Description
As additionally reported to coloplast, though not verified: the patient also experienced pelvic pain, protrusion, erosion, extrusion, urinary issues, recurrence, dyspareunia, heavy discharge, vaginal scarring, permanent disfigurement, and difficulty with daily activities, which ultimately required surgical intervention and revision/removal of mesh on (b)(6) 2024 and (b)(6) 2026.

• Brand Name: RESTORELLE POLYPROPYLENE MESH FOR SACROCOLPOPEXY, SACROCERVICOPEXY, AND SACROHYS
• 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: 24153092
• Report Number: 2125050-2026-00120
• Device Sequence Number: 10030820
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 5708932483834
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 07/09/2026

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: 08/27/2023
• Device Catalogue Number: 501420
• Device Lot Number: 7502429_5014202400
• 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; Not provided; Not provided
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/13/2026; 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2020
• 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: Hospitalization; Disability; Other; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Unknown