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U.S. Department of Health and Human Services

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

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ETHICON INC. DERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
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
Product complaint # : (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? 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 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.
 
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Brand NameDERMABOND PRINEO 22CM MSH 3.8ML ADHESIVE
Type of DeviceSURGICAL 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 Key11168485
MDR Text Key229528268
Report Number2210968-2021-00338
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222
Device Catalogue NumberCLR222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/13/2021 Patient Sequence Number: 1
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