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

Model Number	MSI-2015
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Surgeon has been directed to mesh suture tips & tricks maf29 for guidance on suture sizing.
Event or Problem Description
Midline and ostomy site hernias, cdc 1 case.The size o duramesh was used to close the ostomy site.There was a mesh underneath it.At 4 hours after surgery, the patient was noted to have bleeding in the drains.He was taken back to surgery, where a hematoma at the ostomy site was noted.The duramesh o was found to be in two pieces, with intact knots at either end.The divided duramesh size o may have led to tissue tearing and the hematoma.The patient had the hematoma evacuated, and the area was closed with another duramesh 0.He is fine on his postoperative visit at 1 week number of patients: 1.

• 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 60610
• Manufacturer Contact: richard kearns ; 1444 north astor street; ste 3; chicago, IL 60610 ; 2063902146
• MDR Report Key: 24723561
• Report Number: 3025431509-2026-00001
• Device Sequence Number: 10161329
• Product Code: GAW
• UDI-Device Identifier: 00850008298080
• UDI-Public: 00850008298080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K211178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 03/27/2026

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-2015
• Device Catalogue Number: MSI-2015
• Device Lot Number: D906KTE
• 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: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White