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	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend.No trends were noted for complaints on this lot number.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.
Event or Problem Description
According to the available information, the customer discovered a [mesh] tear upon opening the package.The product was not used in the patient.A new product was opened and successfully used.
Event or Problem Description
According to the available information, the customer discovered a [mesh] tear upon opening the package.The product was not used in the patient.A new product was opened and successfully used.
Additional Manufacturer Narrative
A restorelle mesh was received for evaluation.Examination revealed a tear in two fiber strands of the mesh.Photos of the mesh were forwarded to the contract manufacturer (cm) for further evaluation.Upon further review, the cm noted that the affected sewn area was examined against the applicable sewing acceptance criteria.Localized yarn damage was observed in the sewn area.The appearance is consistent with possible needle strikes during the sewing process; however, it was not possible to conclusively determine whether the observed damage represents one or more discrete needle strikes as defined in the work instruction.The acceptance criteria are based on confirmed needle strikes that result in yarn breakage, with allowable limits dependent on location.Based on visual assessment and the available evidence, it cannot be confirmed that the documented acceptance criteria were exceeded.A review of the device history record by the contract manufactured 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 (Section G): MINNEAPOLIS
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23526825
• Report Number: 2125050-2025-01775
• Device Sequence Number: 9140709
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 5708932483834
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: GB
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/25/2026

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: 10234181_5014202400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 11/11/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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
• Patient Sex: Unknown