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

Model Number	J422H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2022 and suture was used.The patient recovered and was discharged on the 5th day after surgery.On the 15th day after surgery , the patient found a little exudation at the abdominal operation port and went to the hospital for examination.It can be seen that 1/4 of the abdominal surgical site is red, with light yellow secretion flowing out.After the doctor gives the secretion bacterial culture + drug sensitivity examination, the wound dressing is changed.External application of baiduobang, abdominal incision frequency spectrum and strengthening anti-inflammatory treatment.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.Attempts are being made to obtain the following information.To date no response has been provided.Please provide the patient's weight and bmi at the time of index procedure.On what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? please describe any medical/surgical intervention required for this suture event including dates and results.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.What is the patient's current status? if applicable, will product be returned? if so, please provide the return date and tracking information.
Additional Manufacturer Narrative
(b)(4) date sent to the fda: 7/21/2022 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information: b7 additional information was requested and the following was obtained: please provide the patient's weight and bmi at the time of index procedure.----unable to provide on what tissue was the suture used? -- --skin what was the tissue condition (normal, thin, calcified, fragile, diseased)? ----secretion of tissue fluid, poor healing please describe any medical/surgical intervention required for this suture event including dates and results.----routine preparation before cesarean section did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? ----none other relevant patient history/concomitant medications? ----none what is the physician¿s opinion as to the etiology of or contributing factors to this event? ----a variety of factors lead to wound infection.The patient is obese.The probable rate is poor healing caused by fat liquefaction please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).----local infection were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? ----no did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? ----preventive measures of antibiotic intravenous infusion before operation were cultures performed? if so, please provide the results.----yes, no results available what is the patient's current status? ----no re visit, unable to trace the current status of the patient if applicable, will product be returned? if so, please provide the return date and tracking information.----no.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device history lot : a manufacturing record evaluation was performed for the finished device qlmdzz/j422h13 batch number, and no non-conformances were identified.

• Brand Name: VCL CT BRD UD 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.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14824892
• Report Number: 2210968-2022-04869
• Device Sequence Number: 14625157
• Product Code: GAM
• UDI-Device Identifier: 10705031039735
• UDI-Public: 10705031039735
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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 Expiration Date: 09/30/2025
• Device Model Number: J422H
• Device Catalogue Number: J422H
• Device Lot Number: QLMDZZ
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 09/13/2022
• Initial Report FDA Received Date: 06/26/2022
• Supplement Report FDA Received Date: 07/21/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female