• 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. PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT 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. 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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Event Date 03/22/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4). Additional information has been requested however not received to date. If further details are received at a later date a supplemental medwatch will be sent. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved: dermabond prineo, monocryl and pdsii sutures caused and/or contributed to the post-operative complications: allergic contact dermatitis, erythema and itching, bilateral erythematous rash, pruritus, described in the article? does the surgeon believe there was any deficiency with the ethicon products: dermabond prineo, monocryl and pdsii sutures , used in these procedures? 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: web address: doi: 10. 1177/22925503211015448. Note: events reported on mw# 2210968-2022-00469, mw# 2210968-2022-00470, mw# 2210968-2022-00471, mw# 2210968-2022-00472, mw# 2210968-2022-00473,mw# 2210968-2022-00474, mw# 2210968-2022-00476, mw# 2210968-2022-00477, mw# 2210968-2022-00478, mw# 2210968-2022-00479, mw# 2210968-2022-00480.
 
Event Description
It was reported via journal article: title: type iv hypersensitivity reaction to dermabond (2-octyl cyanoacrylate) in plastic surgical patients: a retrospective study the aim of our study is to evaluate the incidence and characteristics of contact dermatitis post application of dermabond (trade name prineo manufactured by ethicon) in patients who underwent plastic surgical breast procedures (mastopexy and reduction mammoplasty) in our hospital over the last 3 years. Between january 2017 and december 2019, a total of 60 patients had underwent 2 layered closure of skin incisions using interrupted 4-0 polydioxanone (pds) for dermal layer and continuous 4-0 monocryl sutures for closure of subcuticular layer this was followed by application of dermabond (prineo) over the closed incision lines. The mean age of the patients was 38 years (range 28-65 years. All of these 4 patients had developed signs and symptoms of allergic contact dermatitis in their second post-operative week. The contact dermatitis was treated by oral and local application of steroids and oral anti-histaminic medication. Acute symptoms like erythema and itching subsided on an average within 2 weeks of the treatment. Reported postoperative complications included: patient 1 ((b)(6)) experienced allergic contact dermatitis, erythema and itching. Patient 2 ((b)(6)) experienced allergic contact dermatitis, bilateral erythematous rash and itching. Patient 3 ((b)(6)) experienced allergic contact dermatitis, bilateral rash and pruritus. Patient 4 ((b)(6)) experienced allergic contact dermatitis, erythema and pruritus on 8th post-operative day. In conclusion, there is a significant risk of developing type iv hypersensitivity reaction (allergic contact dermatitis) post application of dermabond over the suture lines. Hence it is recommended that the patients should be well-informed and consented for possibility of such post-operative complication prior to any application of the dermabond.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13283058
MDR Text Key288986545
Report Number2210968-2022-00475
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
K082289
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial
Report Date 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received12/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/18/2022 Patient Sequence Number: 1
-
-