MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 18IN 7-0 D/A TG140-8; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J546G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Granuloma (1876); Inflammation (1932)
Date of Event	12/02/2020
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 the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: were there any alleged deficiencies noted with the suture that could have contributed to the patient¿s post-operative complications as mentioned in the event description? there were no deficiencies noted with the suture seen in the operating room.Were there any treatments prescribed given to the patient? patients were treated with aggressive topical steroids.Was any surgical intervention performed? please explain- no surgical intervention was required.What was the event day and procedure date?- i do not have surgical dates for all of the patients but some of them were (b)(6) 2020.What is the lot number?- i do not have the lot numbers for the sutures.What is the current condition of the patient- the patients have improved with topical.Steroids but required more frequent clinic visits and topical therapy.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events for 5 patients submitted via 2210968-2021-00137, 2210968-2021-00143, 2210968-2021-00147 and 2210968-2021-00148.
Event or Problem Description
It was reported that the patient underwent a vitrectomy and/or plaque brachytherapy procedure on (b)(6) 2020 and the suture was used for conjunctival and/or scleral closure.It was reported that there has been no change to suture technique.There were no deficiencies noted with the suture seen in the or.The patient developed early post-operative granuloma, inflammation and was treated with aggressive topical steroids at 1 week or 1 month visits.The patient has improved with topical steroids but required more frequent clinic visits and topical therapy.There was no surgical intervention required.
Additional Manufacturer Narrative
Date sent to the fda: 01/14/2021.Attempts are being made to clarify 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.The patient demographic info: age, gender, weight, bmi at the time of index procedure? name and/or indication of index surgical procedure ((b)(6)2020)? lot number? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any pre-existing signs/symptoms of active inflammation prior to this surgical procedure? when the doctor observed inflammation and granuloma first time (# of post-op days/weeks)? location of granuloma? other relevant patient comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to these events (inflammation, granuloma)? what is the patient¿s current status? 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 Manufacturer Narrative
Date sent to the fda: 01/25/2021.H6 component code: g07002 device not returned.The following information was requested, but unavailable: the patient demographic info: age, gender, weight, bmi at the time of index procedure? name and/or indication of index surgical procedure (b)(6) 2020? lot number? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? were there any pre-existing signs/symptoms of active inflammation prior to this surgical procedure? when the doctor observed inflammation and granuloma first time (# of post-op days/weeks)? location of granuloma? other relevant patient comorbidities/concomitant medications? what is physician¿s opinion as to the etiology of or contributing factors to these events (inflammation, granuloma)? what is the patient¿s current status? 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.

• Brand Name: VCL CT BRD VIO 18IN 7-0 D/A TG140-8
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11136772
• Report Number: 2210968-2021-00145
• Device Sequence Number: 3698755
• Product Code: GAM
• UDI-Device Identifier: 10705031041097
• UDI-Public: 10705031041097
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2020

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: J546G
• Device Catalogue Number: J546G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/12/2021; 01/21/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 01/14/2021; 01/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention