MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 5-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J571G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932); Necrosis (1971); Local Reaction (2035); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pc-(b)(4).Attempts have been made to retrieve the device.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.The patient demographic info: 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, i.E., normal or thin, calcified, fragile, diseased? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction).What was the onset date, time from the index surgery? was medical intervention required to treat the patient condition? results.Does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? other relevant patient history/concomitant medications.Lot #? if applicable, will product be returned, return date, tracking information ¿ any usused samples with the same lot that can be returned? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient current status?.
Event or Problem Description
It was reported that a patient underwent an eye procedure on an unknown date and suture was used.Within seven to ten days, the suture eroded out of the eyelid.The patient experienced an inflammatory reaction to the suture causing the tissue to spit the suture and wound dehiscence.The surgeon opined that there was not an infection, but a chemical reaction which caused necrosis of the skin muscle and tarsus.The patient was treated with steroid drops.A different product was used to reclose the area.The current patient status is unknown.Additional information has been requested.

• Brand Name: VICRYL SUTURE 18"(45CM) 5-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8102528
• Report Number: 2210968-2018-77328
• Device Sequence Number: 1599338
• Product Code: GAM
• UDI-Device Identifier: 10705031041332
• UDI-Public: 10705031041332
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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 Catalogue Number: J571G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention