MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 12IN 6-0 D/A RD-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J446G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/27/2020
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 a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: the patient demographic info: weight, bmi at the time of index procedure.The patient is (b)(6) years old female.On what tissue was the suture used? on the muscle.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? no further information is available.What were current symptoms following the index surgical procedure? onset date? no further information is available.Other relevant patient history/concomitant medications =>no further information is available.Lot number.The lot number is unknown.If applicable, will product be returned, return date, tracking information.No sample will be returned.What is the patient¿s current status?.The patient visits hospital regularly.
Event or Problem Description
It was reported that the patient underwent unilateral strabismus surgery on (b)(6) 2020 and suture was used on the muscle.The procedure was performed by simultaneous rotation method and reverse rotation method.After the surgery, rinderon was administered.After a week, during follow-up inspection, the patient complained that the view was slightly vague.Post-op it was reported that the patient may have experienced papillitis.Eye inflammation was suspected, so the patient visited university hospital, and the symptom was diagnosed as uveitis.Rinderon was administered again, and the patient has been under follow-up.The surgeon opined that the suture might have been related to the symptom.It was reported the surgeon opined that inflammatory reaction can happen during the hydrolysis process of sutures.Surgeon opined they did not think that the suture was the direct cause.A contributing factor was reported to be that there is a possibility that infection occurred because the patient touched the eye with a hand.The patient visits the hospital regularly.Treatment plan will be determined on follow-up.No additional information was received.

• Brand Name: VCL CT BRD VIO 12IN 6-0 D/A RD-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9879051
• Report Number: 2210968-2020-02356
• Device Sequence Number: 526584
• Product Code: GAM
• UDI-Device Identifier: 10705031039971
• UDI-Public: 10705031039971
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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: J446G
• Device Catalogue Number: J446G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 YR