MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE POLYPROPYLENE MESH FOR SACROCOLPOPEXY, SACROCERVICOPEXY, AND SACROHYS; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Obstruction/Occlusion (2422); Prolapse (2475); Constipation (3274); Dyspareunia (4505); Urinary Incontinence (4572); Pelvic Pain (4865)
Date of Event	11/23/2024
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 in veeva 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 patient had a restorelle and altis implanted in (b)(6) 2024.Reportedly the patient experienced urinary tract infection (klebsiella pneumoniae) treated with antibiotics, vaginal discharge, pelvic pain, urinary retention and difficulty voiding.Upon examination there was visible vaginal mesh erosion and a palpable induration along the urethra, consistent with mesh impingement "[altis]".The patient underwent vaginal excision of eroded altis mesh and urethrolysis under general anesthesia.Findings included a: 4x4 mm vaginal sling exposure.The mesh was identified as being exposed through the vaginal mucosa, with areas of associated inflammation and tissue necrosis.The mesh was also palpated along the urethra.This report captures the restorelle.
Event or Problem Description
As reported to coloplast, though not verified: the patient had a restorelle and altis implanted in (b)(6) 2024.Reportedly the patient experienced urinary tract infection (klebsiella pneumoniae) treated with antibiotics, vaginal discharge, pelvic pain, urinary retention and difficulty voiding.Upon examination there was visible vaginal mesh erosion and a palpable induration along the urethra, consistent with mesh impingement "[altis]".The patient underwent vaginal excision of eroded altis mesh and urethrolysis under general anesthesia.Findings included a: 4x4 mm vaginal sling exposure.The mesh was identified as being exposed through the vaginal mucosa, with areas of associated inflammation and tissue necrosis.The mesh was also palpated along the urethra.This report captures the restorelle.
Additional Manufacturer Narrative
Correction: b7.Other relevant history: obesity, decreased estrogen, parity.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.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 experienced recurrent rectocele and stabbing pain in right side of the lumbar spine and hips with certain movements.The patient also experienced difficulty with evacuation of bowel movements, pelvic pressure and urine leakage.
Additional Manufacturer Narrative
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.
Event or Problem Description
As additionally reported to coloplast, though not verified: in an effort to rectify her pelvic organ prolapse, on or about(b)(6), 2024, patient underwent a robotic laparoscopic sacral colpopexy procedure with insertion of pubovaginal sling to treat her pelvic organ prolapse and stress urinary incontinence, along with a hysterectomy, posterior colporrhaphy and cystoscopy.Patient implanted with altis and restorelle xl.Unfortunately, complications arose after patient was discharged.Within a few weeks, patient began experiencing discharge at her suture lines, and post-operative pain and fever.On or about (b)(6), 2024,patient went to emergency department and patient was diagnosed with vaginal discharge, urinary tract infection, fever, pain and discharge from her suture lines.On or about (b)(6),2025, patient underwent a removal of the coloplast altis sling to rectify its vaginal mesh erosion and urethral obstruction, during which the doctor successfully removed the eroded mesh.Patient also experienced dyspareunia, and difficulty with daily activities prior to the surgical intervention.

• 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: 23991341
• Report Number: 2125050-2026-00039
• Device Sequence Number: 13317536
• 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: 2024
• 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,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: 03/07/2026
• Device Catalogue Number: 501330
• Device Lot Number: 9018122_5013302400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/07/2026; 05/12/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Unknown