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

Catalog Number	501450
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735); Erosion (1750); Micturition Urgency (1871); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Impaired Healing (2378); Prolapse (2475); Ambulation or Postural Difficulties (2544); Hematuria (2558); Intermenstrual Bleeding (2665); Nervous System Injury (2689); Constipation (3274); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	04/01/2017
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 y contour mesh implanted in (b)(6) 2017 and from (b)(6) 2017 experienced the following: paravaginal defect, muscle weakness, absence of bulbocavernous/ anal wink reflexes, urinary tract infection, e-coli, acute on chronic cystitis, pain, foul smelling urine, abnormal pudendal nerve latency and recurrent cystocele/ vault prolapse (failed pelvic organ prolapse repair).In (b)(6) 2019, a restorelle directfix mesh was used for cystocele repair.Reportedly, post procedure the patient experienced incision separation with chronic discharge, granulation tissue, hematuria, recurrent urinary tract infections, worsening pain, suture extrusion, tenderness on palpation, increased resting tone of pelvic floor muscles, mesh exposure, difficulty walking, constipation with defecatory dysfunction, anal spasm, recurrent grade 2 cystocele, further examination under anesthesia, flap excision of midline vaginal mesh exposure and prolene sutures, eugenol allergy (component of polypropylene), recurrent enterocele and ultimate mesh excision and placement of allograft.
Additional Manufacturer Narrative
This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Complaints of this nature are monitored and captured within the product risk documentation except ambulatory difficulties.There are no clinical studies or literature to support a specific causal relationship between restorelle and ambulatory difficulties.No further action or corrective action is required at this time.The additional restorelle device referenced in b5 is captured under a separate medwatch report.
Event or Problem Description
Reportedly, the patient also experienced vaginal bleeding, overactive bladder, dyspareunia, vaginal irritation with rash/blistering, inflammation, scar tissue, e-coli treated with medications and continued decline in health.Patient was seen by allergist and was not allergic to polypropylene mesh material, but was informed components over time could cause sensitivity.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR ANTERIOR 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: 21349900
• Report Number: 2125050-2025-00193
• Device Sequence Number: 15412924
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• 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: 2019
• 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,Followup
• Report Date (Section B): 03/13/2025

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: 11/10/2021
• Device Catalogue Number: 501450
• Device Lot Number: 6458203_5014502400
• Was Device Available for Evaluation?: 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: 02/10/2025
• Supplement Report FDA Received Date: 03/07/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RESTORELLE Y CONTOUR; RESTORELLE Y CONTOUR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female