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	Erosion (1750); Fever (1858); Micturition Urgency (1871); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Sepsis (2067); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Hematuria (2558); Intermenstrual Bleeding (2665); Dysuria (2684); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Interstitial Cystitis (4862); Abnormal scarring (4896)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient underwent intervention for stress urinary incontinence and pelvic organ prolapse.Following the intervention, the patient reportedly experienced: no bladder control, pain, the need for multiple trigger point injections, rigid cystoscopy, bladder hydrodistension, post cystoscopy retention and increased pain, ongoing chronic dysuria, bladder pain syndrome, interstitial cystitis, pelvic floor dysfunction, frequency, urgency, nocturia, urinary tract infections requiring antibiotics, reduced quality of life, hematuria, enuresis, dyspareunia, abnormal vaginal discharge, vaginal spotting, fever, nephritis, sepsis, erosion, nausea, infection, inflammation, difficulty with bowel movement and the need for complete excision of mesh.
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.
Additional Manufacturer Narrative
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.Should additional information become available, a follow up report will be filed.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.A supris device also implanted in the patient is captured under a separate medwatch report.
Event or Problem Description
As additionally reported to coloplast, though not verified: the patient also experienced recurrent stress urinary incontinence and scarring.
Additional Manufacturer Narrative
Complaints of this nature are monitored and captured within the product risk documentation excluding nausea.Clinical assessment determined nausea is not related.Other explanation exist as nausea is a well-known symptom related to pyelonephritis.No further action or corrective action is required at this time.H6: health effect - clinical code e1020 removed.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20658802
• Report Number: 2125050-2024-01839
• Device Sequence Number: 17944799
• 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: 2018
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 02/10/2025

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 501420
• Device Lot Number: 6186455_5014202400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2018
• 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: 45 YR
• Patient Sex: Female