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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 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.
 
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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
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13227799
MDR Text Key288782137
Report Number2210968-2022-00291
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 01/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Date Manufacturer Received12/17/2021
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: 01/11/2022 Patient Sequence Number: 1
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