MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE POLYPROPYLENE MESH FOR SACROCOLPOPEXY, SACROCERVICOPEXY, AND SACROHYS; PELVIC ORGAN PROLAPSE SURGICAL MESH, SYNTHETIC POLYMER

Catalog Number	501440
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Discomfort (2330); Prolapse (2475); Sexual Dysfunction (4510)
Date of Event	10/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, a restorelle mesh was implanted in (b)(6) 2018.From 2022, the patient with this device experienced: recurrent vaginal klebsiella, rectocele, abdominal pain, cystocele-midline, back pain, pain with prolonged sitting, pelvic pain and underwent removal of pelvic mesh, harvest of rectus fascia, abdominal sacral colpopexy using autologous rectus fascia, posterior and perineal repair and bilateral oophorectomy via general anesthesia.Recurrent rectocele, inability to have sex and feeling of bruised lower abdomen were reported post procedure.
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 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.

• Brand Name: RESTORELLE POLYPROPYLENE MESH FOR SACROCOLPOPEXY, SACROCERVICOPEXY, AND SACROHYS
• 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: 20462486
• Report Number: 2125050-2024-01637
• Device Sequence Number: 7765960
• Product Code: OTO
• UDI-Device Identifier: 05708932483964
• UDI-Public: 05708932483964
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2024

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 Expiration Date: 02/27/2021
• Device Catalogue Number: 501440
• Device Lot Number: 6018573_5014402400
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2018
• 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: 55 YR
• Patient Sex: Unknown