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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 Rash (2033); Tissue Damage (2104)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). The following additional information was requested and the following was received: please provide photos - no photos available. Initial procedure date a few weeks ago, no specific date. What date did the reaction occur post op? no specific date known. How was the reaction treated in addition to antibiotics (product removed; reoperation; reclosure; prescription steroids; prescribed)? if so, please clarify. The doctor removed the prineo, and prescribed antibiotics. Please indicate any medical or surgical interventions performed. No. Please describe how was the adhesive was applied on the tape. Applied the product to the tape, per ifu. What prep was used prior to, during or after prineo use? nothing. Was a dressing placed over the incision? if so, what type of cover dressing used? no dressing. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no allergies. Is the patient hypersensitive to pressure sensitive adhesives? no. Were any sensitivity tests performed? no do you have the lot number involved? no. What is the physicians opinion of the contributing factors to the reaction? the cyanoacrylate caused the skin reaction. What is the most current patient status? patient is fine, no skin reactions. Is the product or representative sample (product from the same lot number) available for evaluation? no product available. Patient demographics: initials / id; age or date of birth; bmi ; gender - don't want to disclose patient information. Patient pre-existing medical conditions (ie. Allergies, history of reactions) no pre-existing medical conditions. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? no. The following additional information was requested and not yet clarified: please specify type of orthopedic procedure name? did each patient have both a hip and knee replacement? to date the device has not been returned and no additional information has been received. 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 an orthopedic procedure on an unknown date and topical skin adhesive was used. The patient returned, two weeks post operatively, complaining of skin rash and blisters, 10 to 15 cm along the incision line. The doctor removed the adhesive. The patient was prescribed and treated with antibiotics. The current patient status is healed. 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 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 Key8861023
MDR Text Key153271427
Report Number2210968-2019-85161
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 07/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
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 Received08/07/2019
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: 08/05/2019 Patient Sequence Number: 1
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