PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2020-03-02 for PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT manufactured by Ethicon Inc..

Event Text Entries

[186284872] (b)(4). Attempts to obtain the following information have been made and no response to date. If further details or the device are received at a later date a supplemental medwatch will be sent. Was the case discussed in this article previously reported to ethicon? If yes, please provide a complaint reference number. Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[186284873] It was reported via a journal article a patient underwent a left shoulder hemiarthroplasty on an unknown date and topical skin adhesive was used. Title: severe wound complication due to prineo surgical dressing in shoulder hemiarthroplasty. Authors: ryan c. Pate, md, michael w. Neumeister, md citation: jbjs case connector (2020); 10 (1): e0306. Doi: 10. 2106/jbjs. Cc. 18. 00306 a (b)(6) year old female patient with left shoulder osteoarthritis underwent a left shoulder hemiarthroplasty. During the procedure, the wound was closed using the dermabond prineo system (ethicon). The patient had a severe and progressive reaction during the first 2 weeks that necessitated debridement and skin grafting. Three months after surgery, the patient was doing well. The surgeons using this closure method should be aware of potential reactions that may initially mimic infection. It is important to initiate appropriate treatment including removing the dressing, topical steroids, and/or oral antihistamines, antibiotics, and possible surgical wound debridement. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2210968-2020-01642
MDR Report Key9774610
Report SourceHEALTH PROFESSIONAL,LITERATUR
Date Received2020-03-02
Date of Report2020-02-05
Date Mfgr Received2020-03-02
Date Added to Maude2020-03-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer StreetP.O. BOX 151, ROUTE 22 WEST
Manufacturer CitySOMERVILLE NJ 08876
Manufacturer CountryUS
Manufacturer Postal08876
Manufacturer Phone6107428552
Manufacturer G1ETHICON INC.-SAN LORENZO PR
Manufacturer StreetROAD 183, KM. 8.3
Manufacturer CitySAN LORENZO 00754
Manufacturer Postal Code00754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Generic NameSURGICAL SEALANT
Product CodeOMD
Date Received2020-03-02
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerETHICON INC.
Manufacturer AddressP.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US 08876


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-02

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