MAUDE Adverse Event Report: ETHICON INC. MCRYL VIO 36IN 1 S/A CTX; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y399H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Purulent Discharge (1812); Pain (1994); Post Operative Wound Infection (2446); Not Applicable (3189)
Date of Event	04/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (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 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.Date of index surgical procedure? product lot number? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre- or intra-operation? when was the re-opening procedure performed? were cultures performed? results? how infection was treated? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? other relevant patient history/concomitant medications? if applicable, will any suture be returned, return date, tracking information? the patient demographic info: age, weight, bmi at the time of index procedure? adverse events were submitted via 2210968-2020-03933, 2210968-2020-03935, 2210968-2020-03937 and 2210968-2020-03938.
Event or Problem Description
It was reported that the patient underwent a c-section procedure in 2020 and the suture was used on uterus.The patient returned four weeks post op complaining of pain.Initially the patient was provided with oral antibiotics however pain did not subside.It was also noticed some cellulitis and thereafter a surgeon decided to re-open.Presence of puss was found on rectus sheath.The washed out procedure was performed and a secondary suture placed.The surgeon is unsure whether event is suture related.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 06/09/2020.Additional information was requested, and the following was obtained: reached out to the obgyn who reported the event.He has advised he does not have this information.Date of index surgical procedure? product lot numbers of involved stratafix spiral monocryl plus, vicryl plus, stratafix symmetric pds and monocryl sutures? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre- or intra-operation? when was the re-opening procedure performed? were cultures performed? results? how infection was treated? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status? other relevant patient history/concomitant medications? if applicable, will any suture be returned, return date, tracking information? the patient demographic info: age, weight, bmi at the time of index procedure? 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: MCRYL VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10058178
• Report Number: 2210968-2020-03935
• Device Sequence Number: 3052905
• Product Code: GAN
• UDI-Device Identifier: 10705031059108
• UDI-Public: 10705031059108
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K960653
• 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,Followup
• Report Date (Section B): 05/05/2020

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: Y399H
• Device Catalogue Number: Y399H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention