MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J532H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pocket Erosion (2013); Fluid Discharge (2686)
Date of Event	11/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a a side perineotomy which was performed at vaginal delivery on (b)(6) 2021 and suture was used.The cervix was examined at the end of the delivery, and no laceration of vaginal fornix was found.The vaginal fornix was sutured with absorbable sutures.At the time of unit rounds on the morning of the 6th postoperative day, the patient had a small amount of light red secretion from the perineal incision, and absorbable suture was observed to be exposed, and the wound was slightly ruddy.Considering rejection to the suture, ceftriaxone sodium was added for anti-infective treatment, kangfuxin liquid for oral use and external use for perineal wound.Infrared irradiation was used to promote wound healing.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device qpmeaa batch number, and no non-conformances were identified.(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure? were there any pre-existing signs/symptoms of active infection/inflammation prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were any pre-op cleansing procedures or products changed recently? if yes, please describe.What is the location of the tissue that the suture was placed? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was suture initially placed (interrupted or continuous)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the exposed suture removed? was re-suturing performed? if yes, with what? was ceftriaxone sodium and kangfuxin liquid given for prophylactic treatment? were cultures done? results? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? were there all symptoms resolved after treatment? did the wound heal?.

• Brand Name: VCL CT BRD VIO 54IN 2-0 D/A CT-1,CP-1
• 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; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12882334
• Report Number: 2210968-2021-12143
• Device Sequence Number: 12035864
• Product Code: GAM
• UDI-Device Identifier: 10705031040984
• UDI-Public: 10705031040984
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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: 11/30/2025
• Device Model Number: J532H
• Device Catalogue Number: J532H
• Device Lot Number: QPMEAA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2020
• 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: 32 YR
• Patient Sex: Female