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	Bacterial Infection (1735); Erosion (1750); Fever (1858); Granuloma (1876); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Discomfort (2330); Prolapse (2475); Dysuria (2684); Dyspareunia (4505); Genital Bleeding (4507)
Date of Event	05/09/2013
Type of Reportable Event	Serious Injury
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.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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.
Event or Problem Description
As reported to coloplast, though not verified, the legal representative stated the patient with this device experienced abnormal vaginal discharge, spotting/ vaginal bleeding, pain, low grade fewer, visible sutures, tenderness at incision, chronic vaginal infections and vaginal granuloma.Mesh revision and excision of vaginal granuloma under general anesthesia was performed.There was no visible mesh eroding through into the vaginal mucosa, but there was a granuloma over the left anterior vaginal mucosa over what was likely the path of the sling as well as a taut area of tissue in the findings.Several areas of inflammatory tissue were noted.A bowel resection was also performed secondary to diverticulitis.
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.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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.
Event or Problem Description
As additionally reported to coloplast, though not verified, the patient with the device also experienced vaginal pain and bleeding for the last 6-8 weeks.Normal exam except protruding mesh on the right upper corner of the vaginal apex.Pvr 150 cc.Mesh revision surgery scheduled for next year.Also reported but likely not restorelle related, laparoscopic-assisted sigmoid resection with cecorectal anastomosis (cra) and vaginal repair secondary to diverticulitis with intraoperative consultation for a vesicovaginal fistula ¿ unknown anesthesia.A small fistulous area on the right lateral cuff edge was identified and oversewn robotically.Granulation and persistent vagina lesion/tissue in the vaginal cuff co2 fulguration of granulation tissue with amniofix application and closure of the defect in the vaginal cuff ¿ general anesthesia.
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.The device was not returned for evaluation.Without the benefit of analyzing the device, coloplast 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.
Event or Problem Description
As additionally reported to coloplast, though not verified, the patient with the device also experienced vaginal pain and bleeding secondary to exposed vagina mesh.Excision of exposed vaginal mesh under general anesthesia.Pathology diagnosis of reactive squamous-lined granulation tissue with chronic inflammation and foreign body-type reaction.

• 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: 20547550
• Report Number: 2125050-2024-01726
• Device Sequence Number: 7827552
• 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: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/30/2025

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: 08/31/2015
• Device Catalogue Number: 501420
• Device Lot Number: 3365279_5014202400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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: 10/28/2024
• Supplement Report FDA Received Date: 01/21/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2012
• 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: 53 YR
• Patient Sex: Female