• 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 Itching Sensation (1943); Rash (2033)
Event Date 10/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts have been made to retrieve the device. 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. Additional information was requested and the following was obtained: how was the reaction treated? patient presented to the ed with rash and intense itching throughout the body. Admitted to the pediatric unit and steroids given. What prep was used prior to, during or after prineo use? standard surgical prep. Was a dressing placed over the incision? if so, what type of cover dressing used? prineo then gauze placed and then long leg fiberglass cast applied. Was the site cultured? yes, upon admission both rash had blood cultures. Blood cultures were negative, rash cultures showed "staphyloccus" aureus. Is the patient hypersensitive to pressure sensitive adhesives? none noted. Were any patch or sensitivity tests performed? none. Do you have the lot number involved ¿ operating room may have that information. What is the physicians opinion of the contributing factors to the reaction? no rash was seen at the time of cast removal 2 weeks after surgery, rash developed after cast removed. What is the most current patient status? still on po steroids, mom states there has been marginal improvement. Is the product or representative sample (product from the same lot number) available for evaluation? check with operating room staff. Family did not keep any that was removed from the wound. Patient demographics: id (b)(6), dob (b)(6), ht 138 cm, wt (b)(6), female. Patient pre-existing medical conditions (ie. Allergies, history of reactions): no history of allergies, nkda. Was prineo/"demabond" or skin adhesive used on the patient in a previous surgery or wound closure? procedure name? medial proximal tibial plateau osteotomy. Internal fixation with plate. Was the cast placed during the initial surgery? post operative splint in place for two weeks. Fiberglass cat placed cast removed 2 weeks post op. Cast was taken off less than a week due after applied to pain. Date that the cast was placed? fiber glass cast put on (b)(6). Patient returned (b)(6) complaining of pain. Cast taken off complaining of pain. Was the prineo mesh removed prior to putting on cast? prineo was not removed prior to putting on the cast. Date that prineo was removed? mom did this at home. It was on at (b)(6). Taken off somewhere between (b)(6) and (b)(6). Please provide photos.
 
Event Description
It was reported that the patient underwent an orthopedic procedure on (b)(6) 2018 and topical skin adhesive was used. Post op splint in place for two weeks. Fiberglass cast placed (b)(6). The cast was removed (b)(6). The patient presented to the hospital on (b)(6) with rash and intense itching throughout the body. The patient was admitted, and steroids were administered. Additional information has been 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 PR 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8077714
MDR Text Key127371942
Report Number2210968-2018-77192
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 Physician Assistant
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
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: 11/16/2018 Patient Sequence Number: 1
-
-