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

Catalog Number	501520
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified the patient was implanted with restorelle y.The device failed, having eroded into the vaginal wall.Patient underwent subsequent surgery to remove the device on (b)(6) 2023.The mesh had folded over on itself and formed a wad.Removing the mesh required the surgeon to also remove patient's right fallopian tube and right ovary.Patient suffered a complete anterior vaginal prolapse due to mesh removal surgery.On (b)(6) 2023, patient underwent another surgery to correct the vaginal prolapse.
Additional Manufacturer Narrative
As no lot # was provided, a review of the device history record, complaint history database, non-conformances and capas could not be completed.B3: estimated date.
Event or Problem Description
Additional information was reported to coloplast, though not verified.Following the implant of restorelle y, the patient had progressively worsening pain related to the vaginal mesh and the removal of the mesh in (b)(6) 2023 was difficult.Following the removal, it was documented that the patient had recurrent grade 4 cystocele, recurrent grade 2 rectocele and complete anterior vaginal prolapse.The patient underwent anterior and posterior colporrhaphy, vaginal epithelium trimming, rectal examination and cystoscopy in (b)(6) 2023.
Additional Manufacturer Narrative
Correction: h11.Lot review.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.This complaint was investigated to the extent information was provided to coloplast.Due to the nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.

• 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: 20055335
• Report Number: 2125050-2024-01275
• Device Sequence Number: 7977951
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 5708932528108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123914
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/13/2023
• Device Catalogue Number: 501520
• Device Lot Number: 7570226_5015202400
• 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: 08/23/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2020
• 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: 77 YR
• Patient Sex: Unknown