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  

Event Description

It was reported via journal article: title: to assess whether 2-octyl cyanoacrylate skin adhesive (dermabondtm topical skin adhesive, ethicon) is the ideal wound closure technique in cardiac surgery limiting surgical site infection the aim of our study is to evaluate the effects of the topical skin adhesive 2-octyl cyanoacrylate prineo (dermabondtm topical skin adhesive, ethicon), used as the final layer in sternotomy closure in patients undergoing cardiac surgery on the incidence of postoperative surgical site infection.Between january 1st 2015 to december 31st 2018, a total of 1604 divided into two groups by virtue of the type of wound closure technique.Group 1 n=840 (2-octyl cyanoacrylate skin adhesive(prineo) ; group 2 n=764 (staples/steristrip under opsite dressing).The mean age was (b)(6).Both groups were homogeneous in terms of the risk factors of mediastinis : diabetes mellitis (requiring insuline), obesity (bmi>30), smoking, renal impairment, length of surgery, mean age and sex.The rate of 551 was found lower in group 1 (closure with dermabond prineo), 1,90 %, compared to the other group, 4,19%.Group 1 was also superior in terms of lower length of hospital stay.Furthermore, the subsequent decline in 551 after 2017, since the adoption of prineo, has been highlighted by the observation made by swissnoso in their annual analysis of ssi.Reported postoperative complication in group 1 included n=? surgical site infection (ssi).In conclusion, dermabond adhesive has proved, in our practice, to be a safe wound closure treatment that provides an ideal healing environment with its antimicrobial protection, reducing considerably surgical site infection and helps to reduce the economic burden of current care (frequent dressing changes).

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.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: respiration: 2020; conference: ssc/sscs ssp/ssts joint annual meeting 2020.Davos switzerland, 99(8): 733.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 13285925
• MDR Text Key: 288984607
• Report Number: 2210968-2022-00486
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• 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: 12/22/2021
• 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