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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT SURGICAL SEALANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4). This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. (b)(4).
 
Event Description
It was reported via journal article: "title: skin closure with 2-octyl-cyanoacrylate and polyester mesh after primary total knee arthroplasty offers superior cosmetic outcomes and patient satisfaction compared to staples: a prospective trial" authors: not reported. Citation: not reported. The aim of this prospective study was to compare the outcomes of patients receiving 2-octyl-cyanoacrylate glue and polyester mesh for skin closure after total knee arthroplasty (tka) versus staples for the following outcomes at 6- and 12 weeks postoperative: (1) visual analog scale (vas) patient satisfaction with wound cosmesis per tka and (2) wound-related complications per tka, including stitch abscess, wound hematoma, wound dehiscence, superficial surgical site infection (ssi), deep ssi, and periprosthetic joint infection (pji), readmission, and reoperation. Between january 15, 2018 to february 27, 2019, 54 patients undergoing 60 tkas were included in the study that were divided into two group: 30 tkas (male
=
8, female
=
22; mean age
=
62 ± 8 years; mean bmi
=
33 ± 5. 2 kg/m^2) were under glue and polyester-mesh group, and 30 patients (male
=
15, female
=
15; mean age
=
62 ± 7 years; mean bmi
=
35 ± 7. 5 kg/m^2) were under control group. For the glue and polyester mesh group, closure of the subcutaneous layer was performed using a unidirectional barbed number 4-0 monofilament absorbable suture (stratafix, number 4 monofilament suture, ethicon) with inverted interrupted knots. The skin edges were approximated using adhesive polyester mesh (prineo, ethicon). 2-octyl cyanoacrylate (glue) (dermabond, ethicon) was applied in a single layer on the polyester mesh and allowed to dry for a minimum of thirty seconds. The wound was then covered with surgical dressing. The polyester mesh was removed during the 4-week post-operative visit. In the glue and polyester mesh group, a (b)(6) year old male patient had superficial ssi. On his post-operative day-4, he required readmission for treatment of severe cellulitis. He left against medical advice before he received intravenous antibiotics and required a second readmission for insert of a peripherally inserted central catheter (picc) line. Ultimately, the patient successfully completed an intravenous course of antibiotics. Also, in the same group, a (b)(6) year old male patient had wound dehiscence. On his post-operative day 11, he fell directly on the operative leg resulting in complete wound dehiscence with exposure of his prosthesis. He was seen in the emergency department and admitted to the hospital where he underwent treatment with debridement, antibiotics, irrigation, and implant retention (dair). He ultimately completed a 4-week course of iv antibiotics followed by an additional 4-week course of oral antibiotics. His wound was completely healed, and he had a well-functioning tka at his last orthopaedic visit. In conclusion, the skin closure with polyester mesh and glue offers superior patient satisfaction and cosmetic outcomes compared to staples for wound closure in tka patients.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9443531
MDR Text Key185480587
Report Number2210968-2019-90686
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
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: 12/10/2019 Patient Sequence Number: 1
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