MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 18IN 5-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP495G
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) this is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m.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.1.If in your possession, may we have a copy of your operative report? 2.Does ethicon have your permission to contact your surgeon, in the event that we would like to request more clinical information to be used for a product quality complaint investigation? 3.If so, please provide your surgeon¿s name and contact information and fill out the attached consent form? (email, phone number, address) note: related events reported via 2210968-2024-00870 and 2210968-2024-00871.
Event or Problem Description
It was reported that the patient underwent a gallbladder removal procedure on (b)(6)2023 and suture was used.Post-op, all of the other suture lines had healed aside from the bellybutton.The suture was not healing and would not scab.The patient had silver put on the suturing to help sterilize it and cauterize it on (b)(6)2024.It was called it a split stitch.The suture would not dissolve.It was stated that possible outcomes for patient include having the suture taken out and re-sutured with a different type.It is unclear if the patient is having a reaction/allogenic reaction to the suture or not.

• Brand Name: MCRYL+ UD 18IN 5-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 18627675
• Report Number: 2210968-2024-00871
• Device Sequence Number: 7964212
• Product Code: GAM
• UDI-Device Identifier: 10705031046580
• UDI-Public: 10705031046580
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MCP495G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/01/2024
• 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