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); Erythema (1840); Fistula (1862); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Abdominal Cramps (2543); Hematuria (2558); Dysuria (2684); Dyspareunia (4505); Fecal Incontinence (4571); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced mesh erosion and exposed mesh, vaginal bleeding, lower abdominal and back pain, dark brown discharge, cramping, colovaginal fistula, inflammatory changes, erythema in the area, tenderness to touch, dyspareunia, urinary tract infection, hematuria, incomplete bladder emptying, fecal leakage and urine culture positive for e.Coli.The mesh was firmly embedded and not able to be removed manually, mesh was ultimately surgically removed.Intraoperative findings noted no fistula present, and mesh was completely free of all bowel.
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, 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
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, 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.Correction: b1: removed product problem.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced mesh erosion and exposed mesh, vaginal bleeding, lower abdominal and back pain, dark brown discharge, cramping, colovaginal fistula, inflammatory changes, erythema in the area, tenderness to touch, dyspareunia, urinary tract infection, hematuria, incomplete bladder emptying, fecal leakage and urine culture positive for e.Coli.The mesh was firmly embedded and not able to be removed manually, mesh was ultimately surgically removed.Intraoperative findings noted no fistula present, and mesh was completely free of all bowel.As reported to coloplast, though not verified, the patient with this device additionally experienced dysuria, frequency, goes through two to three pads per day and pelvic pain.
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, 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.
Event or Problem Description
As reported to coloplast, though not verified, the patient with this device experienced mesh erosion and exposed mesh, vaginal bleeding, lower abdominal and back pain, dark brown discharge, cramping, colovaginal fistula, inflammatory changes, erythema in the area, tenderness to touch, dyspareunia, urinary tract infection, hematuria, incomplete bladder emptying, fecal leakage and urine culture positive for e.Coli.The mesh was firmly embedded and not able to be removed manually, mesh was ultimately surgically removed.Intraoperative findings noted no fistula present, and mesh was completely free of all bowel.As reported to coloplast, though not verified, the patient with this device additionally experienced dysuria, frequency, goes through two to three pads per day and pelvic pain.As reported to coloplast, though not verified, it was additionally reported that the patient experienced bacterial vaginosis.

• 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: 21267751
• Report Number: 2125050-2025-00129
• Device Sequence Number: 14359430
• 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: 2021
• Device Explanted Year: 2023
• 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): 08/08/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 501420
• Device Lot Number: 7676491_5014202400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2020
• 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: 44 YR
• Patient Sex: Female