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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); Impaired Healing (2378); Skin Inflammation/ Irritation (4545)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information received: did the patient experience a post-op device malfunction? no, 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 was given to patient to manage the contact dermatitis. Patient status/ outcome / consequences? yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc. )? patient experience allergic contact dermatitis on 2nd exposure to dermabond prineo, symptoms include redness, itchiness and poor healing around the inferior wound edge, was other medical intervention (e. G. X-rays, additional procedures, prescriptions, otc, revision) required: yes, if yes, describe: topical steroids was prescribed, is the patient part of a clinical study: unknown, device property of? none, device in possession of: none. Additional information has been requested however not received. Attempts to obtain device made but not received to date. If further details are received at a later date a supplemental medwatch will be sent. 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? was patient screening done prior the procedure, e. G. Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? 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)? was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? current patient status. Please clarify if product is available for return?.
 
Event Description
It was reported a patient underwent a right total knee replacement on an unknown date in 2022 and topical skin adhesive was used. The patient had experienced allergic contact dermatitis on right knee after use of adhesive post- (tkr) surgery. Allergic reaction was discovered 1 week post-op. Symptoms include redness, itchiness and poor healing around the inferior wound edge. Topical steroids were given to patient to manage the contact dermatitis. 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
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13995790
MDR Text Key288503003
Report Number2210968-2022-02354
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
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
Is the Reporter a Health Professional? No
Date Manufacturer Received05/12/2022
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: 04/04/2022 Patient Sequence Number: 1
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