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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 Problem Skin Inflammation/ Irritation (4545)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Title: should we stick with surgical glues? the incidence of dermatitis after 2-octyl cyanoacrylate exposure in 102 consecutive breast cases commenting on the article by nigro et al. 1 about the incidence of dermatitis after 2-octyl cyanoacrylate exposure in 102 consecutive breast cases, the authors would like to report 3 cases of extreme reaction to the use of dermabond prineo (ethicon) on patients who underwent body-contouring surgery. Complications include very severe reaction within 24 to 48 hours after prineo skin closure system application (n
=
3). In conclusion, prineo is a fast and effective wound management system for the closure of long incisions frequently encountered in excisional body-contouring surgery and we continue to use it. However, we would like people to be aware of this extreme reaction.
 
Manufacturer Narrative
(b)(4). Attempts are being made to obtain the following information. To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that any of the ethicon products involved (prineo) caused and/or contributed to the post-operative complications (very severe reaction, removal of the prineo, oral corticosteroid treatment) described in the article? does the surgeon believe there was any deficiency with any of the ethicon products ( prineo) used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. 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: plastic and reconstructive surgery, january 2021, page 160e; doi: 10. 1097/prs. 0000000000007447.
 
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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 PR
road 183, km. 8.3
san lorenzo 00754
00754
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key13054116
MDR Text Key288134367
Report Number2210968-2021-12826
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeAS
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 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2021
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: 12/21/2021 Patient Sequence Number: 1
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