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	Erosion (1750); Pain (1994); Wound Odor (4866)
Date of Event	09/03/2024
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 reportedly had an altis and restorelle directfix implanted.The patient reportedly experienced bladder sling erosion coming from the right vaginal wall with a foul smell coming from the eroded sling, mesh erosion, and severe groin pain radiating down the legs.Excision of the altis sling was performed under general anesthesia.

• 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: 21767713
• Report Number: 2125050-2025-00538
• Device Sequence Number: 8811898
• 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: 2017
• 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): 04/03/2025

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: 02/15/2020
• Device Catalogue Number: 501460
• Device Lot Number: 5503731_5014602400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2017
• 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: ALTIS SINGLE INCISION SLING SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Female