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

Model Number	5013202400
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Prolapse (2475); Intermenstrual Bleeding (2665); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	03/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced device exposure, protrusion of the device, bleeding, infections, pelvic floor disfunction, pelvic pain, vaginal pain, dyspareunia, urinary urgency problems, scarring, and difficulty with daily activities.Patient had explantation of the device.
Event or Problem Description
Additional information received on 6/12/2023 indicates the patient was experiencing an abnormal vaginal discharge.
Additional Manufacturer Narrative
Corrections: item number, catalogue number, udi number, medical device name.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.
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.This complaint was investigated to the extent information was provided to coloplast.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
Additional information reported to coloplast on 09/25/2024 indicates that the patient continues to experience pain, abnormal vaginal discharge, frequency, dyspareunia, urgency and stress urinary incontinence.Reportedly, on examination there is scar tissue on the anterior forchette of cervix where mesh may have been removed, cervical prolapse, and cystocele.There was a plan for exam under anaesthesia but no confirmation that this occurred.
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.This complaint was investigated to the extent information was provided to coloplast.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 on (b)(6) 2026, though not verified: the patient experienced pelvic pain, vaginal bleeding, vaginal irritation and vaginal discharge with foul odor.Urinary analysis positive for rbcs and wbc esterase: large.Erosion and exposure of implanted vaginal mesh to surrounding organ or tissue with 2 cm grayish brown cut portion of mesh extruding through cervical os.

• 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; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16437028
• Report Number: 2125050-2023-00222
• Device Sequence Number: 3126971
• Product Code: OTO
• UDI-Device Identifier: 05708932483223
• UDI-Public: 05708932483223
• 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: 2016
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 05/13/2026

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: 06/23/2018
• Device Model Number: 5013202400
• Device Catalogue Number: 501320
• Device Lot Number: 4620066_5013202400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 06/12/2023; 06/12/2023; Not provided; Not provided
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 07/07/2023; 07/07/2023; 10/17/2024; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2015
• 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: 47 YR
• Patient Sex: Unknown