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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Burning Sensation (2146)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Additional information: component code: (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: prineo and dermabond, caused and/or contributed to the post-operative complications (itching, burning sensation, medication required) described in the article? does the surgeon believe there was any deficiency with the ethicon products: prineo and dermabond, 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: world j orthop 2021 november 18; 12(11): 931-937 doi: 10.5312/wjo.V12.I11.931.Journal article attached.Note: events reported on mw# 2210968-2022-00290.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported in a journal article: allergic dermatitis after knee arthroscopy with repeated exposure to dermabond prineo¿ in pediatric patients: two case reports two cases of pediatric acd upon second exposure to dermabond prineo¿ (ethicon) after knee arthroscopy.Both cases presented within two weeks of the inciting second exposure.The cases resolved with differing described combinations of sterile cleaning, diphenhydramine, and antibiotic administration.Case 1: six days after an arthroscopic left medial meniscus repair and bone marrow aspirate injection, a (b)(6) year-old female reported increasing itching and a burning sensation around the incision sites that progressed to feeling like her left knee was ¿on fire.¿ dermabond prineo was used.Case 2: the second patient is a (b)(6) year-old female who presented one week after her left medial meniscal allograft transplantation and reconstruction of anterior cruciate ligament (acl), posterior cruciate ligament (pcl), and medial collateral ligament (mcl) with complaints of two days of itching around her operative sites.And dermabond was used.This case report elucidates the rare complication of allergic dermatitis secondary to dermabond prineo¿ repeat exposure use in pediatric arthroscopy.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. SAN LORENZO; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13227799
• MDR Text Key: 288782137
• Report Number: 2210968-2022-00291
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female