MAUDE Adverse Event Report: ETHICON, LLC COATED VICRYL; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	J267H
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
0 vicryl suture broke off as attending was closing incision.Imaging taken to retrieve loose piece.Radiologist read and confirmed no pieces left in pt w/attending surgeon.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; route 22 west, p.o. box 151; somerville NJ 08876
• MDR Report Key: 9340915
• Report Number: 9340915
• Device Sequence Number: 2801669
• Product Code: GAM
• UDI-Device Identifier: 10705031038394
• UDI-Public: (01)10705031038394
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 10/28/2019
• Report Date (Section F): 10/28/2019

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 Model Number: J267H
• Device Catalogue Number: J267H
• Device Lot Number: PGM835
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 60
• Date Report Sent to FDA: 10/28/2019