MAUDE Adverse Event Report: ETHICON INC. GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP; SUTURE, ABSORBABLE, NATURAL

Model Number	1915G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an eyelid procedure on an unknown date and suture was used.Post-op, the patient developed a bad reaction to the suture, as diagnosed by an ophthalmologist.The patient had prolonged chemosis.The patient was told by the ophthalmologist that they had an allergy to the suture material.The patient¿s symptoms resolved after steroid drops and medrol dose pack over a few months.Additional information was requested.
Additional Manufacturer Narrative
(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.H6 component code: g07002 device not returned.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: 1 upper blepharoplasty, 1 quad blepharoplasty (affected lower lids) w prolonged chemosis, 1 lower bleph (prolonged chemosis).Chemosis patients were told they had an allergy to the suture material by optho (skin pinch 5-0 fast gut closure and a transconj fat reduction closed with 2-3 interrupted 5-0 fast gut).Resolved after steroid drops and medrol dose pack over a few months.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.How many suture devices caused or contributed to chemosis in patient 1? additional information was received on 22-jun-2023 that stated: "1 upper blepharoplasty, 1 quad blepharoplasty (affected lower lids) w prolonged chemosis, 1 lower bleph (prolonged chemosis)" please clarify: were all these procedures performed on patient 1 or were these procedures done on different patients? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure.Date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? how was the suture originally tied (multiple knots, square knot, etc.)? please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Please provide the onset date/time of the reaction from the initial procedure.Were any pre-op cleansing procedures or products changed recently? if yes, please describe.Does the patient have a known allergic history to any medical devices, food and/or medication? how was it determined the patient was allergic to the suture? was allergy testing performed? if so, please describe with 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? what is the patient's current status? lot number? are there any photos available? note: related events reported via 2210968-2023-05222.

• Brand Name: GUT PL FAG UD 18IN 5-0 S/A PC-1 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17342249
• Report Number: 2210968-2023-05223
• Device Sequence Number: 20464024
• Product Code: GAL
• UDI-Device Identifier: 10705031002913
• UDI-Public: 10705031002913
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• 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 Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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: 1915G
• Device Catalogue Number: 1915G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown