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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information, when placing the restorelle mesh, a tear/ hole was noted in the mesh.After placing a suture, the physician contacted the manufacturer's representative to discuss the tear.Ultimately, it was decided to remove the suture and mesh.A second mesh was successfully placed.
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
According to the available information, when placing the restorelle mesh, a tear/ hole was noted in the mesh.After placing a suture, the physician contacted the manufacturer's representative to discuss the tear.Ultimately, it was decided to remove the suture and mesh.A second mesh was successfully placed.
Additional Manufacturer Narrative
A restorelle polypropylene mesh was received for evaluation.Examination of the mesh revealed a hole in the middle of part of the mesh.Microscopic examination of the mesh where the hole was revealed rough and irregular surfaces, indicating stress may have been exerted.Blood residue was also noted on the mesh.The information received indicated that the mesh tore during implant.Quality confirmed the tear in the mesh.As the area of mesh where the hole was noted was rough and irregular, this indicated that excess stress was most likely exerted to result in the separation noted.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, nonconformances and capas revealed no trends for this lot.

• 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: 19519745
• Report Number: 2125050-2024-00883
• Device Sequence Number: 8337774
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 501420
• Device Lot Number: 9464569_5014202400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: Other
• Patient Sex: Unknown