MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 1 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J261H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Pain (1994); Swelling/ Edema (4577)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to receive additional information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Questions for patient #1: the patient demographic info: age, gender, weight, bmi at the time of index procedure? date of index left tha procedure? on what tissues were vicryl sutures (j261h and j945h) used? product lot numbers for j261h and j945h? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any pre-existing signs/symptoms of active inflammation/infection prior to this surgical procedure? did the patient receive prophylactic antibiotics pre-, intra- or post operation? please specify.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Did the operating surgeon observe any suture deficiency or anomaly before, during or after the suture placement? please specify.Please explain/clarify what does it mean by ¿eruptions (5- and 8-months post op)¿? how were both ¿eruptions¿ resolved? were oral antibiotics used both times at 5- and 8-months post op? please specify.Other relevant patient factors/comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent an elective left tha procedure on unknown date and the suture was used.The patient experienced post-op inflammation at the suture site.The patient presented with pain, erythema and swelling along the suture line 8 months post op.The patient was placed on oral antibiotics when inflammatory markers were found to be elevated, esr and crp.It was also reported that the patient had two such eruptions, 5 and 8 months post op, and both have resolved.Additional information has been requested.

• Brand Name: VCL CT BRD UD 27IN 1 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12488669
• Report Number: 2210968-2021-08593
• Device Sequence Number: 3736177
• Product Code: GAM
• UDI-Device Identifier: 10705031038356
• UDI-Public: 10705031038356
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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 Model Number: J261H
• Device Catalogue Number: J261H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention