MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J397H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Related events captured via 2210968-2022-04078, and 2210968-2022-04972.
Event or Problem Description
It was reported that a patient underwent a lower uterine segment cesarean section on (b)(6) 2022 and suture was used for suturing the skin.The intraoperative suturing was smooth.On (b)(6) 2022, the doctor found during ward round that the patient had pale bloody exudation when squeezing the incision, without other special symptoms and signs.The patient was given incision gauze drainage and dressing change.On (b)(6) 2022, the patient still had pale bloody exudation in the incision, without other special symptoms or signs.The doctor gave the patient extended wound debridement and dressing change.On (b)(6) 2022, the patient's incision exudation was reduced, and the patient was given debridement and suturing of abdominal wall incision under spinal anesthesia.During the operation, the suture of the original abdominal wall incision used for suturing the anterior rectus sheath was found broken in the middle.After the doctor cleaned the wound with normal saline, the wound was scraped with vascular forceps, and the anterior rectus sheath was continuously sutured with silk suture and the skin and subcutaneous tissues were intermittently sutured.The patient was in stable condition currently, and no subsequent adverse event report was received.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14854783
• Report Number: 2210968-2022-04973
• Device Sequence Number: 14843518
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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: J397H
• Device Catalogue Number: J397H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 25 YR
• Patient Sex: Female