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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); Unspecified Infection (1930); 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.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.
 
Event Description
It was reported in a journal article entitled: 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.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.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.
 
Manufacturer Narrative
Product complaint#: (b)(4).
 
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Brand Name
PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of Device
SURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
MDR Report Key9434286
MDR Text Key185547469
Report Number2210968-2019-90629
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Type of Report Initial,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/18/2019
Initial Date FDA Received12/06/2019
Supplement Dates Manufacturer Received11/18/2019
Supplement Dates FDA Received12/09/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age57 YR
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