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 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.

• 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 PR; road 183, km. 8.3; san lorenzo 00754 ; 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13054116
• MDR Text Key: 288134367
• Report Number: 2210968-2021-12826
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• 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 Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2021
• 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