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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 Biocompatibility (2886)
Patient Problems Skin Irritation (2076); No Code Available (3191)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. Additional information was requested and the following was obtained: what is the initial procedure date? (b)(6) 2018. What date did the reaction occur on? (b)(6) 2018. How large of an area does the reaction cover? approximately 1 foot in length extending just medial to the incision to about 4 inches laterally. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify - the prineo along with the aquaseal dressing was removed. Steristripes were gently placed, and the patient was instructed to wash the area with soap and water. Two antibiotics were also prescribed for 10 days, keflex 500mg tid and bactrim ds. What is the most current patient status? after about 2 weeks the patient¿s skin cleared up and now he is doing well, with no issues.
 
Event Description
It was reported that a patient underwent a knee replacement procedure on (b)(6) 2018 and topical skin adhesive was used. Two and a half weeks post op the patient had a skin reaction that was bright red and blistered. The surgeon removed the topical skin adhesive, along with the aquaseal dressing. Steristrips were gently placed, and the patient was instructed to wash the area with soap and water. Two antibiotics were also prescribed for 10 days. After about two weeks the patient¿s skin cleared up and the patient is now doing well, with no issues. Additional information was 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
road 183, km. 8.3
san lorenzo
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8265805
MDR Text Key133709617
Report Number2210968-2019-78532
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 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2019
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: 01/21/2019 Patient Sequence Number: 1
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