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

Catalog Number	501420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Neuropathy (1983); Pain (1994); Abnormal Vaginal Discharge (2123); Prolapse (2475); Dyspareunia (4505); Sexual Dysfunction (4510)
Date of Event	08/12/2016
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.
Event or Problem Description
As reported to coloplast, though not verified: the patient had restorelle polypropylene mesh implanted in 2016.Reportedly, from 2021 the patient has experienced postcoital bleeding, cervical erosion, inflammation, vaginal lesions, vaginal discharge, grade 1 recurrent rectocele, vaginal pain, vaginal bleeding in absence of intercourse and inability to have intercourse which resulted in examination under anesthesia in (b)(6) 2023.Intraoperative findings included no evidence of mesh or gore-tex sutures and approximately 4 cm friable/glandular vaginal tissue extending from cervix.Pathology results identified necro inflammatory debris, granulation tissue, marked acute and chronic inflammation, colonies of filamentous bacteria.Vaginal bleeding reportedly continued and further examination under anesthesia was performed.Benign fragments of stromal tissue with inflamed granulation consistent with ulceration were noted and the mesh was ultimately excised in (b)(6) 2023.During excision, adhesions of sigmoid colon and rectosigmoid into the pelvis were noted in addition to a resolving hematoma.In 2024 the patient reportedly experienced postsurgical neuropathy and had grade 3 recurrent rectocele, minimal anterior/ apical prolapse, foreshortened vagina and minor dyspareunia.The patient is sexually active and not interested in further surgical intervention at this time.
Event or Problem Description
As reported to coloplast, though not verified it was additionally reported: patient had examination (endocervical curettage) under anesthesia.Intraoperative findings: no evidence of mesh or gore-tex sutures, erythema of upper vagina, ~4 cm friable/glandular vaginal tissue extending from cervix, brisk bleeding from cervical os, cervix feels bulky, cervix enlarged/barrel shaped (~6 cm), endocervix concerning for fragmentation of tissue, suspect adenocarcinoma arising in cervical stump.Pathology findings: endocervix curettage: necroinflammatory debris, granulation tissue, marked acute and chronic inflammation, colonies of filamentous bacteria.Examination under anesthesia, multiple tru-cut cervical biopsies.Intraoperative findings: fairly consistent vaginal bleeding, mucosal changes at vaginal apex consistent with chronic irritation, friable cervix.Pathology findings: cervix, biopsy: (benign) fragments of stromal tissue with inflamed granulation tissue consistent with ulceration, scant fibroadipose tissue with chronic inflammation.

• 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: 20097136
• Report Number: 2125050-2024-01329
• Device Sequence Number: 7570890
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• 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: 2016
• 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,Followup
• Report Date (Section B): 08/18/2025

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: 04/27/2019
• Device Catalogue Number: 501420
• Device Lot Number: 5042507_5014202400
• Is the Reporter a Health Professional?: No
• 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: 08/29/2024
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2016
• 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: 51 YR
• Patient Sex: Female