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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT

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ETHICON INC. DERMABOND PRINEO 60CM MSH 3.8ML ADHESIVE SURGICAL SEALANT Back to Search Results
Catalog Number CLR602
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Discoloration (2074); Burning Sensation (2146)
Event Date 05/14/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Attempts to obtain the following information was requested however not received to date. The date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. Please describe how was the adhesive was applied. What prep was used prior to, during or after prineo 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? please clarify adhesive removal around 220 days after surgery? were any patch or sensitivity tests performed? patient demographics: age or date of birth; bmi ; patient pre-existing medical conditions (ie. Allergies, history of reactions). Does the patient use or 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? note: events reported via mw# 2210968-2020-06233 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event Description
It was reported a patient underwent a reduction mammoplasty with prosthesis and abdominoplasty on (b)(6) 2020 and surgical sealant was used. Patient noticed hyperemia around the area covered by the adhesive around the fourteenth day post op, especially in breast and later for scar of the abdomen. Evolving with intense local itching and enlargement of the hyperemic area due to intense urticarial reaction. The adhesive was removed. She used prednisone 20 mg for 7 days, allegra d 180mg for 7 days and loratadine 10mg every 8h and locally using quadriderm. Surgery was without any complications. No history of allergic reaction. Difficult control of local reaction and did not respond to conventional treatment. It lasted for more than 20 days despite treatment. Patient complained of intense burning. The patient had an allergic reaction in the place where prineo 60 was placed, currently is in excellent postoperative evolution. Maintains darkening of the skin at the reaction site. Additional information requested.
 
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Brand NameDERMABOND PRINEO 60CM 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
00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10428742
MDR Text Key204264598
Report Number2210968-2020-06234
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K082289
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 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberCLR602
Device Lot NumberPJJ503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2019
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: 08/19/2020 Patient Sequence Number: 1
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