MAUDE Adverse Event Report: MESH SUTRE, INC DURAMESH; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	MSI-5015
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A review of the surgeon's report indicates that after using duramesh msi-5015 / lot #f404gfr on a surgery performed (b)(6) 2025 the patient was observed on (b)(6) 2025 to require post-surgical intervention.The patient was admitted for an end ileostomy takedown procedure and fascial closure with duramesh.The knots appeared to come unsecured post-surgery.Number of patients: 1.
Additional Manufacturer Narrative
Former end colostomy site had an unraveled knot.The suture was not broken and the fascia was intact.Surgeon reported to manufacturer in a follow-up verbal interview that the device knot became unsecured due to only applying 3 or 4 throws, not alternating, a lapse in technique and user error.Post-surgical inquiry indicated.Patient has fully recovered.

• Brand Name: DURAMESH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): MESH SUTRE, INC; 1444 north astor street; ste 3; chicago IL 60610
• Manufacturer (Section G): MESH SUTURE, INC; 1444 north astor street; ste 3; chicago IL 60610
• Manufacturer Contact: richard kearns ; 1444 north astor street; ste 3; chicago, IL 60610 ; 2063902146
• MDR Report Key: 22472418
• Report Number: 3025431509-2025-00001
• Device Sequence Number: 4272414
• Product Code: GAW
• UDI-Device Identifier: 00850008298134
• UDI-Public: 00850008298134
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Model Number: MSI-5015
• Device Catalogue Number: MSI-5015
• Device Lot Number: F404GFR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White