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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); Skin Irritation (2076); Tissue Damage (2104)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). 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. (b)(4). Additional information was requested and the following was obtained: what are the procedure name(s) and date(s)? total knee replacement. What does the reaction look like and how large of an area does the reaction cover?redness and blistering only under the prineo tape. Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify. Product removed and precautionary antibiotics prescribed. What is the most current patient status? unknown at this time. Are photos available of the reaction? no photos available. Initial procedure date? no, not available. What post op date did the reaction occur? reaction occurred prior to the 2 week follow up. Please describe how was the adhesive was applied on the tape ¿ as per ifu; sales rep has reviewed technique with pa. What prep was used prior to, during or after prineo use? unknown. Was a dressing placed over the incision? if so, what type of cover dressing used? unknown. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? no, known allergies. Is the patient hypersensitive to pressure sensitive adhesives? unknown. Were any patch or sensitivity tests performed? unknown. Do you have the lot number involved ? unknown. What is the physicians opinion of the contributing factors to the reaction? unknown. What is the most current patient status? unknown. Patient demographics: initials / id; age or date of birth; bmi ; gender - unknown. Patient pre-existing medical conditions (ie. Allergies, history of reactions). Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.
 
Event Description
It was reported a patient underwent a total knee replacement on an unknown date and topical skin adhesive was used. Patient developed a rash under the adhesive with blistering and redness postoperatively. The product was removed and precautionary antibiotics were prescribed. No device available for return. 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 PR
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8729783
MDR Text Key149057469
Report Number2210968-2019-83225
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 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
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 Received06/05/2019
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: 06/24/2019 Patient Sequence Number: 1
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