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

Model Number	J267H
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During closing process of surgical incision, suture o vicryl cp-1 broke.

• Brand Name: COATED VICRYL
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): ETHICON, LLC; 475 c street; los frailes industrial park, suite 401; guaynabo PR 00969
• MDR Report Key: 12631531
• Report Number: 12631531
• Device Sequence Number: 1402057
• 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): 09/29/2021
• Report Date (Section F): 09/29/2021

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: No Information
• Device Model Number: J267H
• Device Catalogue Number: J267H
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/29/2021