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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 CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)
Event Date 04/01/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information: did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes. Did the patient require revision surgery or hardware removal? no. If no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? topical steroids and antihistamines was prescribed to patient for the allergic reaction. Patient status/ outcome / consequences? yes. Patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? patient experienced allergic contact dermatitis from second use of dermabond prineo, the skin surrounding the wound where prineo was applied was red and itchy. Was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: yes. If yes, describe. Topical steroids and antihistamines were prescribed. Additional information has been requested however not received to date. If further details are received at a later date a supplemental medwatch will be sent. Were topical steroids prescription strength? is a photo available of the patient reaction? what was the procedure date? what date /day post op was the reaction noted? please describe how was the adhesive was applied. What prep was used prior to, during or after adhesive 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? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? current patient status. Product not available for return.
 
Event Description
It was reported a patient underwent a total knee replacement on the left knee on an unknown date in (b)(6) 2021 and topical skin adhesive was used. Allergic contact dermatitis (acd) was noticed in patient that had second exposure to adhesive. Symptoms include itchiness, redness of skin surround the wound. Adhesive was removed and patient was treated with topical steroids. 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.
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 Key13625008
MDR Text Key287559539
Report Number2210968-2022-01378
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 02/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLR222US
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
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