MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM; SURGICAL SEALANT

Catalog Number CLR222

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Skin Irritation (2076); Tissue Damage (2104)

Event Date 07/28/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The following information was requested however, not received to date: please provide photos how was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.Please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? what is the physicians opinion of the contributing factors to the reaction/ inflammation/ infection? what is the most current patient status? lot number? is the product or representative sample (product from the same lot number) available for evaluation? patient pre-existing medical conditions (ie.Allergies, history of reactions).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.

Event Description

It was reported a patient underwent a total knee replacement on (b)(6) 2019 and topical skin adhesive was used.The patient returned to the general practioner on (b)(6) 2019, post-op day 5 with skin reaction and surgical site infection risk at the surgical site.Inflammation and small blisters.Dressing removed.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).The following additional information was requested and obtained: if the reaction is on the knee, was the product applied while knee was extended or flexed? flexed.How was the reaction treated (product removed; reoperation; reclosure; prescription steroids iv steroid/topical steroid/oral steroid, antibiotics prescribed)? dressing removed & monitored, treated with topical steroid cream.No revision procedure required.What is the most current patient status? wound reported to be improving.Who applies the product (surgeon/assistant/nurse)? ortho registrar.What prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? chlorhexidine starting procedure.Wiped clean with sterile saline prior to application of prineo.Was a protective, dry wound dressing such as gauze applied and was it applied only after the liquid topical skin adhesive has completely polymerized and the dermabond¿ prineo¿ is no longer tacky to the touch? no dressing applied over the top.Type of dressing use on top of prineo (e.G.Honeycomb/opsite/gauze/crepe) none.Was the application site cleansed thoroughly with saline or isopropyl alcohol to remove any remaining blood, fluids, or topical medications/anaesthetics, including skin preps, and then patted dry? saline wipe and gauze used to wipe dry was a thin layer applied as per ifu? surgeon and registrar indicate 'yes'.Were any patch or sensitivity tests performed prior to the procedure? no.Did the applier change a fresh pair of glove prior prineo application? removes top glove layer.What is the physicians opinion of the contributing factors to the reaction/ inflammation/ infection? prior exposure to cyanoacrylate.

• Brand Name: DERMABOND PRINEO 22CM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8917227
• MDR Text Key: 155102428
• Report Number: 2210968-2019-85952
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR