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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Retention (2119); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572)
Date of Event	08/01/2023
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 second restorelle implanted.
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.B3: estimated date.
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.
Additional Manufacturer Narrative
G2: correction.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.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 accordingly.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

• 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: 20533029
• Report Number: 2125050-2024-01708
• Device Sequence Number: 8247722
• Product Code: OTO
• 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: 2023
• 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
• 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: 01/19/2026
• Device Catalogue Number: 501420
• Device Lot Number: 8921840_5014202400
• 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
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2023
• 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: Other
• Patient Age: 62 YR
• Patient Sex: Female