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 Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abrasion (1689); Adhesion(s) (1695); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Prolapse (2475); Dyspareunia (4505); Sexual Dysfunction (4510); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Vaginal Dryness (4864); Pelvic Pain (4865)
Date of Event	10/24/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient had restrolle mesh implanted in (b)(6) 2017.From (b)(6) 2017, the patient experienced palpable gore-tex sutures holding the mesh in place, pressure and cramping, vaginal discharge, stage 2 cervical prolapse, vaginal bleeding, superficial abrasions on inferior mucosal surface, erosion of the posterior wall of the vagina secondary to suture to affix mesh, clipping and removal of exposed sutures, vaginal mesh exposure, pelvic pain, vaginal dryness and itching, urinary urgency and difficulty starting urinary stream.Patient attended emergency department in (b)(6) 2023 with grade 3 cervical prolapse with significant pain.The patient reportedly also experienced episodes of acute retention, stress urinary incontinence, dyspareunia and partner complaining of feeling something sharp during intercourse.The mesh was excised in (b)(6) 2023.Lysis of adhesions, posterior repair, vaginal mucosa trimming, rectal examination and cystoscopy were performed.A new restorelle was implanted with gore-tex sutures to attach it to the existing/ previously implanted restorelle.From (b)(6) 2023, there is some ongoing tenderness with palpation of the levator, symptoms of occult stress urinary incontinence as well as some voiding dysfunction.This report captures the first restorelle implanted.
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.B3: estimated date.
Additional Manufacturer Narrative
Correction: g2 report source updated to consumer.H6 clinical code e1419 removed.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.Based on the available information, the reported complaint is identified in the risk management documentation excluding vaginal dryness.There are no clinical studies or literature to support a specific causal relationship between vaginal dryness and pelvic mesh.Vaginal dryness is a common condition that can occur at any age, but it's particularly prevalent during and after menopause.Defining a confounding factor, women who undergo pelvic mesh surgery may be in the same age group that experiences menopausal symptoms, including vaginal dryness.Hormonal changes (especially decreased estrogen levels), certain medications, cancer treatments, autoimmune disorders, stress and anxiety are more well-known risk factors or causes of vaginal dryness and vaginal mucosa atrophy.Complaints are routinely monitored for complaint trends as part of post market surveillance.No corrective action is required at this time.
Event or Problem Description
As additionally reported, though not verified: the patient also experienced extrusion, neuromuscular problems, pelvic floor dysfunction, vaginal scarring, disfigurement and difficulty with daily activities.
Additional Manufacturer Narrative
B3: date of event corrected.
Event or Problem Description
As additionally reported to coloplast though not verified: the patient has also experienced mild vaginal tenderness without stricture or point tenderness, urethral hypermobility, mildly elevated baseline pelvic tone with limited voluntary squeeze, vaginal and lower abdominal pain, myofascial pelvic pain, palpable mesh through the proximal posterior vaginal wall on exam and intermittent pelvic pain and urinary leakage which has improved with pelvic floor exercises.

• 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: 20532858
• Report Number: 2125050-2024-01706
• Device Sequence Number: 6682085
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• 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: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 02/15/2020
• Device Catalogue Number: 501420
• Device Lot Number: 5525263_5014202400
• 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: 10/25/2024
• Supplement Report FDA Received Date: 11/04/2024; 04/17/2025; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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: 56 YR
• Patient Sex: Female