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); Diarrhea (1811); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency / Polyuria (2275); Discomfort (2330); Deformity/ Disfigurement (2360); Prolapse (2475); Ambulation or Postural Difficulties (2544); Dysuria (2684); Constipation (3274); Tactile Disorders (4419); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577); Pelvic Pain (4865); Abnormal scarring (4896); Atrophy (4913)
Date of Event	05/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: estimated date.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 underwent vaginal surgery on or about (b)(6), 2022, at which time the boston scientific obtryx transobturator mid-urethral sling system and coloplast restorelle y mesh were implanted.As a result of the mesh that was inserted, the patient suffered numerous injuries, including, but not limited to pain while standing, walking, sitting, lying down, groin pain, pelvic pain, lower back pain, mental pain, scarring, mesh erosion to surrounding tissue, dyspareunia and disfigurement.On (b)(6), 2025, patient underwent mesh removal surgery.
Additional Manufacturer Narrative
B3: estimated date.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 additionally experienced urinary urgency, frequency, urinary tract infection, pelvic discomfort with a pulling sensation, bilateral low back pain without sciatica.Leg swelling, pelvic pain, lower back pain w/ pain down bilateral legs, dull sensation in vaginal wall.Dyspareunia, cramping, vaginal odor and discharge, stress urinary incontinence, burning/intense muscle spasms/contractions, unable to walk.Mostly on bed rest, dysuria, constipation, diarrhea, and removal of mesh from obturator and adductor muscle.
Event or Problem Description
As reported to coloplast, though not verified, the patient additionally experienced elevated ferritin secondary to acute inflammation from nerve damage from pelvic surgery, chronic pelvic pain, nerve pain, sacral pain, mobility issues, numbness in sacrum, urinary frequency, gait abnormality, chronic pelvic pain syndrome with swelling of lower extremities; idiopathic progressive neuropathy; lumbosacral radiculopathy continues with sharp, shooting pain from the right lower back radiating down the lateral right thigh; bilateral sacroiliitis with significant pain, chronic pelvic floor pain/dysfunction, prolapse with diagnosed rectocele, cystocele and vaginal vault prolapse.Pain throughout the day requiring multiple dosing of pain medications, tailbone pain with any movement or physical activity.Using cane to ambulate.Urinary frequency and leakage and inability to empty bladder fully.
Additional Manufacturer Narrative
Correction: b2.Outcomes attributed to adverse event: added disability or permanent damage b3: estimated date.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.

• 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: 23142800
• Report Number: 2125050-2025-01531
• Device Sequence Number: 9857406
• 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: 2022
• Device Explanted Year: 2025
• 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): 08/18/2026

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: 08/15/2024
• Device Catalogue Number: 501420
• Device Lot Number: 8034911_5014202400
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; 08/06/2026
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/12/2025; 05/18/2026; 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2021
• 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: Disability; Required Intervention
• Patient Age: 42 YR
• Patient Sex: Unknown