MAUDE Adverse Event Report: ETHICON, LLC PROLENE; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8702
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Missing sutures.

• Brand Name: PROLENE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON, LLC; 475 c street los frailes; industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 24828398
• Report Number: 24828398
• Device Sequence Number: 18431450
• Product Code: GAW
• UDI-Device Identifier: 10705031045774
• UDI-Public: (01)10705031045774
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/07/2026
• Report Date (Section F): 04/07/2026

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
• Device Model Number: M8702
• Device Catalogue Number: M8702
• Device Lot Number: 10ARC3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Date Report Sent to FDA: 04/07/2026