MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT; SURGICAL SEALANT

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).As no contact information has been provided, no follow up can or will be performed at this time.If further details are received at a later date a supplemental medwatch will be sent.If further details are received at a later date a supplemental medwatch will be sent.This report is related to a journal article; 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.Citation: citation cite: european spine journal.2020.Note: events reported on mw# 2210968-2022-00515.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 journal article: title: a change in protocol of wound care in spinal surgery and its impact on post-operative wound infections in neurosurgery the aim of this study is to determine if closed dressing protocol reduces ssi.All patients diagnosed with ssi (based on inspection, clinics and mri), during the initial stay or at readmission, are prospectively followed.Based on this data, we retrospectively included all primo-operated spine procedures from april 2016 to july 2017 in two different centers (geneva, switzerland, and innsbruck, austria).They were separated in 2 general groups: closed-protocol, where we applied the dressing system dermabond +/- prineo ethicon) (a self-adhering mesh with 2-octyl-cyanoacrylate skin glue, removed after 14 days and conventional-protocol, which included dermal, intradermal sutures or staples.672 patients were included in this study.Reported complication included surgical site infections in conclusion dermabond or dermabond-prineo had the lowest infection rates, but a larger cohort is necessary to demonstrate a significant superiority versus all other closure types.Further investigation via a multicentric controlled randomized trial is planned.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13290905
• MDR Text Key: 286759204
• Report Number: 2210968-2022-00516
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention