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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 Problem Rash (2033)
Event Date 07/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following information was requested and received: date of the total knee replacement procedure? unknown. It was noted that both topical and oral steroids were administered, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify. Product removed before administering steroids. Please indicate any medical or surgical interventions performed. None. Please describe how was the adhesive was applied on the tape. Single layer with excess liquid wiped off after drying. What prep was used prior to, during or after prineo use? unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? unknown. What is the physicians opinion of the contributing factors to the reaction? dr feels there has been a change in formulation or tape. What is the most current patient status? unknown. 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. Unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Unknown. 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 total knee procedure on an unknown date and topical skin adhesive was used. The patient returned to the doctor on (b)(6) 2019, complaining of a rash on and around the incision site. The doctor prescribed a topical and oral steroid to the patient. Patient currently okay. 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 Key8916957
MDR Text Key155085859
Report Number2210968-2019-85950
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 07/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2019
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 Received07/26/2019
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: 08/21/2019 Patient Sequence Number: 1
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