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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 Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 01/01/2022
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional information has been requested and received. If further details are received at a later date a supplemental medwatch will be sent. (b)(4): patient 1. Patient received a "steroid". What date did the reaction occur on? on (b)(6) 2022. What does the reaction look like and how large of an area does the reaction cover? redness, rash, and erythema under the mesh. Do you have any pictures of the reaction? no. Was there any medical or surgical intervention performed (re-operation; re-closure; wound debridement)? if so, please specify. If medication was prescribed, please clarify if it was prescription strength. A "steroid" per the surgeon. What is the most current patient status? -skin reaction fully resolved as of (b)(6) 2022. Can you identify the lot number of the product that was used? no. Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown. Was any surgical intervention performed? no. Please describe how was the adhesive was applied. The dermabond prineo was applied per the ifu's directed technique per the surgeon and his pa. What prep was used prior to, during or after adhesive use? unknown at this time. Was a dressing placed over the incision? if so, what type of cover dressing used? no per the surgeon and his pa. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no per the surgeon and his pa. Is the patient hypersensitive to pressure sensitive adhesives? no per the surgeon and his pa. Was patient screening done prior the procedure, e. G. Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? no per the surgeon and his pa. Patient demographics: initials/ id, gender, age or date of birth; bmi? unknown at this time. Patient pre-existing medical conditions (ie. Allergies, history of reactions)? unknown at this time. Has the patient used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown at this time. No product is available for return.
 
Event Description
It was reported a patient underwent a total knee arthroscopy procedure on an 3/21/2022 and topical skin adhesive was used. Patient had a skin reaction several days post-op. Patient presented with redness, rash, and erythema per the surgeon. Patient received a steroid reaction resolved after removing the adhesive. 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 Key14428834
MDR Text Key291932141
Report Number2210968-2022-03791
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
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 Received04/19/2022
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: 05/18/2022 Patient Sequence Number: 1
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