MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Cellulitis (1768); Granuloma (1876); Unspecified Infection (1930); Post Operative Wound Infection (2446); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).This report is related to data research, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported via clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing an unknown procedure on an unknown date and suture was used.N = 579 patients (30-day follow-up) and the reported complication experienced by the following with corresponding intervention: 16 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, surgical site infection; 3 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, surgical site infection; 1 patient had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, surgical site infection; 1 patient had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, surgical site infection; 2 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, wound dehiscence; 2 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, wound dehiscence; 2 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, other wound complications; 2 patients had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, other wound complications; 1 patient had complication after the index procedure on 30-day follow-up with the use of the device not present on admission were defined with the diagnosis code, cellulitis/abscess.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to fda: 04/30/2021.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).Date sent to fda: 04/30/2021.

• Brand Name: STRATAFIX SYMMETRIC PDS
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 10792719
• MDR Text Key: 214798186
• Report Number: 2210968-2020-08692
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• 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: 04/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention