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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
Catalog Number CLR222
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Event Date 11/23/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Sent to the fda. Attempts to obtain the following information have been made, no response has been received to date. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. What type of topical steroids were administered? what if any other specific type of medical / surgical treatment was provided to treat the reaction? what prep was used prior to, during or after prineo use? how many layers of adhesive were used over during application? 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? what is the physicians opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi, weight? patient pre-existing medical conditions (ie. Allergies, history of reactions) it was noted prineo was used for prior total knee. Was reaction reported?.
 
Event Description
It was reported a patient underwent a total knee replacement on an (b)(6) 2019 and topical skin adhesive was used. The adhesive was applied into the entire incision length. Patient developed an allergic reaction to adhesive on (b)(6) 2019. The entire mesh area and mesh edges was red and was very itchy. Doctor removed the mesh using saline, applied topical steroids and prescribed oral medication for patient on (b)(6) 2019. Redness subsided slightly by (b)(6) 2019, patient was discharged. Additional information was 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
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9481875
MDR Text Key188031967
Report Number2210968-2019-90996
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
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 11/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/26/2019
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: 12/17/2019 Patient Sequence Number: 1
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