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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT Back to Search Results
Catalog Number CLR222US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Rash (2033)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information was requested and the following was obtained: please provide photos of the rash/ reaction. No photos provided. Procedure name- plastic surgery. Initial procedure date- not known. Please indicate any medical / surgical intervention performed (reoperation)? none known. Please describe how was the adhesive applied on the tape- per ifu. What prep was used prior to, during or after prineo use? not known. Was a dressing placed over the incision? if so, what type of cover dressing used? not known. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not known. Is the patient hypersensitive to pressure sensitive adhesives? not known. Were any patch or sensitivity tests performed? not known. Do you have the lot number involved ? no. What is the physicians opinion of the contributing factors to the reaction? she suspects it may be a bad batch. What is the most current patient status? not known. Is the product or representative sample (product from the same lot number) available for evaluation? no. Patient demographics: initials / id; age or date of birth; bmi ; gender- not known. Patient pre-existing medical conditions (ie. Allergies, history of reactions) not known. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? not know. 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.
 
Event Description
It was reported a patient underwent a plastic surgery procedure on an unknown date and topical skin adhesive was used. Post-operatively, the patient suffered a severe skin rash where the product was applied. The rash was treated with steroids. Two weeks later there was still severe inflammation. As a result, the patient lost a nipple. The patient is currently in good condition. There are no samples to return. Additional information has been requested.
 
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Brand NameDERMABOND PRINEO 22CM SKIN CLOSURE
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8799083
MDR Text Key151327978
Report Number2210968-2019-84404
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,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR222US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2019
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: 07/17/2019 Patient Sequence Number: 1
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