MAUDE Adverse Event Report: ETHICON INC. STRATAFIX UNKNOWN; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.(b)(4).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: what was the procedure date? surgery date (b)(6) 2022.What does the reaction look like and how large of an area does the reaction cover? n/a.What is your current medical status? still rejecting sutures to date.Monocryl 3-0 and stratafix both rejected.Inventory items.Rx arista 3gm smioo2-usa msc and rx arista 1gm sm0005-usa msc.My dermatologist and immunologist are looking into it now but i'd appreciate any manufacturer material for my patch testing.What was the name of the procedure? n/a.What date did the reaction occur on? n/a.Do you have any pictures of the reaction? n/a.It was reported you have an allergic reaction to this material and another type of dissolving suture, please confirm how many sutures/products are involved in this event: n/a.Can you identify the product code and lot number of the product(s) that was(were) used? n/a.Was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.N/a.Could you tell me if there was a prescription for steroids or antibiotics for yours recovery? if yes, please provide medication name, route and dose.N/a.If medication was prescribed, please clarify if it was prescription strength: n/a.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).4.Did you notify the manufacturer of arista about your rare allergic reaction? customer_support@bd.Com.Related medwatch reports: 2210968-2023-00251, 2210968-2023-00250.

Event Description

It was reported by the patient that: i am experiencing a rare allergic reaction to this material and another material and need to patch test to see which one it is.Additional information was requested.

• Brand Name: STRATAFIX UNKNOWN
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• 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: 16132399
• MDR Text Key: 307022052
• Report Number: 2210968-2023-00251
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RX ARISTA 1GM SM0005-USA MSC; RX ARISTA 3GM SMIOO2-USA MSC
• Patient Outcome(s): Other