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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Nausea (1970); Pain (1994); Scar Tissue (2060); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Vomiting (2144); Urinary Frequency / Polyuria (2275); Discomfort (2330); Impaired Healing (2378); Numbness (2415); Prolapse (2475); Intermenstrual Bleeding (2665); Dysuria (2684); Dyspareunia (4505); Cramp(s) /Muscle Spasm(s) (4521); Urinary Incontinence (4572); Swelling/ Edema (4577); Bladder Wall Thickening (4863); Pelvic Pain (4865)
Date of Event	10/18/2019
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 to be associated.The restorelle referenced in b5 is captured under a separate medwatch report.The device was not returned for evaluation.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 implanted in (b)(6) 2016 and a restorelle direct fix implanted in (b)(6) 2018.Reportedly, from (b)(6) 2016, the patient experienced: uncontrolled pain (perineal, abdominal, vulvar and pelvic) requiring medication, hypertonicity, rectal adhesions, recurrent uti with positive urine culture, e.Coli, dyspareunia, urinary retention requiring catheterization, hematuria, need for bladder irrigation, bladder spasms, voiding dysfunction, dysuria, stress urinary incontinence, delayed sensations to void, vaginal defect, persistent bloating and underwent sling excision [restorelle] under general anesthesia.From (b)(6) 2018, the patient also experienced continued pain, urinary tract infections, a small area of dehiscence, small draining hematoma, vaginal discharge with odor and vaginal pressure, cramping, vaginal bleeding, urinalysis positive for nitrites, left leg numbness that subsided, left leg swelling, bladder wall and sigmoid colon thickening, nausea and vomiting, poking sensation with intercourse, bleeding after intercourse, anterior banding with recurrent cystocele, urinary frequency, mesh exposure, vaginal wound, need for medications and emergency room visits.The patient underwent removal of composite vaginal wall graft, suture of vaginal wound and enterocele repair under general anesthesia.Scarring and lichen type changes on right labia noted.

• 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: 21631914
• Report Number: 2125050-2025-00418
• Device Sequence Number: 7536688
• 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: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

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: 11/29/2020
• Device Catalogue Number: 501450
• Device Lot Number: 5925687_5014502400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2017
• 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.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female