MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y CONTOUR; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Abnormal Vaginal Discharge (2123); Intermenstrual Bleeding (2665)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, beginning (b)(6) 2022 sacralcolpopexy mesh exposure, increasingly bothersome pelvic floor dysfunction that negatively impacts quality of life, vaginal mesh excision/revision (restorelle), vaginal mucosa trimming, cystourethroscopy.Increasingly bothersome vaginal mesh exposure and vaginal bleeding that impact quality of life.On (b)(6) 2022 robotic assisted: excision of genitourinary mesh implant (restorelle) and surrounding granulation tissue, extensive lysis of adhesions (1 hour), partial colpectomy.
Event or Problem Description
Additional information received on 2/27/2024 indicated that the patient was also experiencing a brown tinged discharge.

• Brand Name: RESTORELLE Y CONTOUR
• 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: 18894854
• Report Number: 2125050-2024-00403
• Device Sequence Number: 6476359
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (Y/N): N
• PMA/510(K) Number: K123914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• 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): 03/27/2024

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: Lay User/Patient
• Device Catalogue Number: 501520
• 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: 03/13/2024
• Supplement Report FDA Received Date: 03/27/2024
• 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: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Unknown