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 Problems Unspecified Infection (1930); Post Operative Wound Infection (2446)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Does the surgeon believe that any of the ethicon products involved (prineo) caused and/or contributed to the post-operative complications (infection, wound complications and surgical site infection) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products ( prineo) used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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 cite: s.S.Johnston et al./ the spine journal 21 (2021) 45-54.Https://doi.Org/10.1016/j.Spinee.2020.08.017.

Event Description

Title: economic and clinical outcomes of spinal fusion surgeries with skin closure through skin staples plus waterproof wound dressings versus 2-octyl cyanoacrylate plus polymer mesh tape the purpose of this study is to compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (sswwd) or 2-octyl cyanoacrylate plus polymer mesh tape (2opmt).A total of 11,991 patients met the study criteria and underwent spinal fusion surgery for a spine disorder between october 1, 2015 and march 31, 2019.2-octyl cyanoacrylate [dermabond ; ethicon inc, nj, usa]) was used.Reported complications included lower rate of infections, wound complications and surgical site infection.In conclusion in this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2opmt for skin closure was associated with significantly lower ort, los, non-home discharge, and 90-day rates of infections/wound complications as compared with sswwd.

• 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 PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13054494
• MDR Text Key: 288170643
• Report Number: 2210968-2021-12833
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• 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: 11/23/2021
• 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