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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 Itching Sensation (1943); Blister (4537)
Event Date 05/10/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). (b)(4) device not returned. Additional information has been requested and obtained. If further details are received at a later date a supplemental medwatch will be sent is a photo of reaction available? n/a confirm date of procedure was (b)(6) 2021? yes date of reaction? please see original comment. Please describe how the adhesive was applied. Normal prineo application what prep was used prior to, during or after prineo use? i believe duraprep was a dressing placed over the incision? if so, what type of cover dressing used? unknown is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown is the patient hypersensitive to pressure sensitive adhesives? unknown were any patch or sensitivity tests performed? no patient demographics: initials / id, gender, age or date of birth; bmi male/ mid (b)(6) patient pre-existing medical conditions (ie. Allergies, history of reactions) unknown has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? patient had a previous total knee with prineo and had no prior reactions. Was prineo/dermabond skin adhesive used on the patient in a previous surgery or wound closure? yes what is the current status of the patient? unknown no product will be returned.
 
Event Description
It was reported a patient underwent a total knee replacement on (b)(6) 2021 and topical skin adhesive was used. Post op day 3, the patient distal blisters. On day six he began experiencing itching. Patient removed the adhesive on day nine. Patient is currently taking an h2 antagonist and a gram positive effective antibiotic (keflex). 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 Key12012500
MDR Text Key256739920
Report Number2210968-2021-05615
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133864
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2021
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
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: 06/16/2021 Patient Sequence Number: 1
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