MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR POSTERIOR POLYPROPYLENE MESH; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501460
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Bacterial Infection (1735); Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Prolapse (2475); Hematuria (2558); Intermenstrual Bleeding (2665); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Pelvic Pain (4865); Abnormal scarring (4896)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified: the patient had an unknown tvt [transvaginal tape] implanted in 2013 and a restorelle direct fix implanted in 2015.Reportedly from 2019, the patient experienced right flank pain, abdominal pain, microhematuria, frequency, incontinence, pelvic pain, urgency, hypertonicity of bladder, vaginitis, inflammation, postcoital bleeding, abnormal vaginal bleeding, detrusor hyperreflexia of bladder, pain during sex, overactive bladder, brown vaginal discharge, bacterial vaginosis, odor, atypical glandular cells, bacteria morphological consistent with actinomyces species infection, stress urinary incontinence, exposure of vaginal mesh through vaginal wall, recurrent rectocele and scarring.The patient underwent excision of exposed vaginal mesh and posterior colporrhaphy via general anesthesia.Pathology showed surgical mesh with attached inflammatory debris and bacterial colonies.Post excision, the patient reportedly experienced spotting, mild bleeding from prolonged standing, recurrent mesh exposure, partner dyspareunia and overactive symptoms.
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.B3: date is unknown.
Additional Manufacturer Narrative
H6: health effect clinical code e1605 removed as not applicable to the event details.

• Brand Name: RESTORELLE DIRECTFIX POSTERIOR POSTERIOR POLYPROPYLENE MESH
• 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: 22984454
• Report Number: 2125050-2025-01415
• Device Sequence Number: 15683031
• Product Code: FTL
• UDI-Device Identifier: 05708932484084
• UDI-Public: 05708932484084
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted 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
• Report Date (Section B): 09/19/2025

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: 07/31/2016
• Device Catalogue Number: 501460
• Device Lot Number: 3774767_5014602400
• 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
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2013
• 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: 49 YR
• Patient Sex: Unknown