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

Catalog Number	501520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Constipation (3274); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Urolithiasis (4861); Pelvic Pain (4865)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced abdominal pain, bladder spasms, feeling of incomplete emptying of her bowels, constipation, pelvic pain, fluid collection at the site of her mesh with concern for infection (noted on mri), pain with defecation, pelvic floor dysfunction, urinary tract infection, bladder pain, vaginal discharge, trigonitis, mixed stress and urge urinary incontinence, urinary frequency, urgency of urination, nocturia, bladder stone and mesh erosion into the bladder.This resulted in robotic-assisted lysis of adhesions with mesh exploration and cystoscopy under general anesthesia and ultimate mesh removal and cystoscopy under general anesthesia.Post excision cystoscopy notes slight trigonitis without mesh erosion and well healing incision.
Additional Manufacturer Narrative
As an incomplete lot number was provided, a review of the device history record, complaint history database, nonconformance's and capas could not be completed.The device was not returned for evaluation.Without the benefit of analyzing the device, quality cannot comment on the condition of the device.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
As no complete lot # was provided, a review of the device history record, complaint history database, nonconformances and capas could not be completed.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21363830
• Report Number: 2125050-2025-00208
• Device Sequence Number: 8464827
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• 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: 2021
• 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
• Report Date (Section B): 02/26/2025

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 Catalogue Number: 501520
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 63 YR
• Patient Sex: Female