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

Model Number	MSI-2005
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The case was identified in the serious adverse events section of an interim registry report prepared by staff at (b)(6) university in prepration for journal publication in frontiers in surgery.Surgeon reported to manufacturer in a follow-up verbal interview that the device knot became unsecured due to lack of alternating throws, a lapse in technique and user error.Post-surgical inquiry indicates patient has fully recovered.
Event or Problem Description
A review of the surgeon's report indicates that after using duramesh msi-2005 / lot #cb04pyu on a surgery performed (b)(6) 2023 the patient was observed on (b)(6) 2023 to require post-surgical intervention.The patient was originally admitted for a recurrent umbilical hernia measuring 5cm.The defect was repaired using duramesh using a intermittent figure-8 closure technique with knots tied at the end of each intermittent stitch.The knots appeared to come unsecured post-surgery.Number of patients: 1.

• Brand Name: DURAMESH
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): MESH SUTRE, INC; 980 n. michigan ave; suite 1400; chicago IL 60611
• Manufacturer (Section G): MESH SUTURE, INC; 980 n. michigan ave; suite 1400; chicago IL 60611
• Manufacturer Contact: richard kearns ; 980 n. michigan ave; suite 1400; chicago, IL 60611 ; 2063902146
• MDR Report Key: 18342255
• Report Number: 3025431509-2023-00002
• Device Sequence Number: 6739621
• Product Code: GAW
• UDI-Device Identifier: 00850008298080
• UDI-Public: 00850008298080
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K211178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/17/2023

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-2005
• Device Catalogue Number: MSI-2005
• Device Lot Number: CB04PYU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 12/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White