MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE; SURGICAL SEALANT

Model Number CLR222

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

Patient Problems Inflammation (1932); Itching Sensation (1943); Blister (4537)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested and was received.Primary procedure date: unknown, procedure e.G.Tkr?: tkr, surgeon: dr (b)(6), if the reaction is on the knee, was the product applied while knee was extended or flexed? unknown, how long did the reaction occur post primary op? 1 week, describe the reaction (e.G.Blister/red/infected/mild reaction/severe reaction/itch): all of the listed examples, did the patient have to be readmitted for treatment? no, were any iv steroid/topical steroid/oral steroid/other treatments used to manage the reaction? topical steroids, what is the most current patient status? all symptoms are reducing.Who applies the product (surgeon/assistant/nurse)? surgeon.What prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? unknown, 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? unknown, type of dressing use on top of prineo (e.G.Honeycomb/opsite/gauze/crepe) unknown, 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? unknown, was a thin layer applied as per ifu? unknown however surgeon has been using for a long time.Patient hypersensitivity to cyanoacrylate, formaldehyde, or pressure sensitive adhesive and using relatable terms such as hypersensitive to bandages, tape, hobbyist glue, cosmetic eyelashes or artificial nails or any recent exposure? unknown.Were any patch or sensitivity tests performed prior to the procedure? unknown, patient¿s demographics: initials / id; age or date of birth; bmi; gender ¿ unknown, patient pre-existing medical conditions (e.G.Allergies, history of reactions): unknown, was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Did the applier change a fresh pair of glove prior prineo application? unknown, any images available? no.Were the topical steroids prescribed by a physician or purchased over the counter? it was prescribed.The following information has been requested however not received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Can you identify the lot number of the product that was used?.

Event Description

It was reported a patient underwent a total knee replacement on an unknown date in 2020 and topical skin adhesive was used.About one week after surgery, patient had mild to moderate irritation with inflammation, itching and small blistering.Treated with prescription of topical steroids.Symptoms reducing.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11168479
• MDR Text Key: 230259655
• Report Number: 2210968-2021-00335
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLR222
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2020
• 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