• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE SURGICAL SEALANT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following information was requested and obtained: initial procedure date. Surgery date 6/14 - noticed reaction on june 19th when ace wrap was removed by mother. How was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify. Reaction was treated with antibiotics and steroids - pieces of product remained; too tough to remove without further irritating the skin. Please describe how was the adhesive applied on the tape. Proper application steps for use were followed. What prep was used prior to, during or after prineo use? chloroprep wash was used prior to draping the patient and was completely washed away and dried prior to using prineo. Was a dressing placed over the incision? if so, what type of cover dressing used? gauze and ace wrap was used over the prineo. Was the site cultured? if so, what bacteria were identified? don¿t believe the site was cultured. The nurse practitioner commented that she felt it ¿looked like a chemical burn¿. Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? nurse practitioner reported no known allergies to any of the components in prineo. Is the patient hypersensitive to pressure sensitive adhesives? no pre-op allergy tests were performed that nurse practitioner is aware of. Were any patch or sensitivity tests performed? no pre-op allergy tests were performed that nurse practitioner is aware of. What is the physicians opinion of the contributing factors to the reaction? no comment was received from physician on contributing factors to the reaction. What is the most current patient status? no information provided. Is the product or representative sample (product from the same lot number) available for evaluation? no lot number is available for evaluation. Patient pre-existing medical conditions (ie. Allergies, history of reactions). No pre-existing medical conditions were noted. Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? this was the first experience with prineo for the patient. The nurse practitioner was concerned about how to get the remainder of the prineo off without using a vaseline (petroleum based product, or an acetone for fear of causing additional damage to the surrounding skin and wound. 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 an unknown knee surgery on (b)(6) 2019 and topical skin adhesive was used. On (b)(6) 2019, 5 days post operation, patient had a severe reaction to adhesive on patients left leg. Reaction was treated with antibiotics and steroids. Additional information was requested.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8817153
MDR Text Key151896180
Report Number2210968-2019-84580
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 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2019
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 Received06/26/2019
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: 07/23/2019 Patient Sequence Number: 1
-
-