MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM -US SURGICAL SEALANT

Catalog Number CLR602US

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

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Date 01/29/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4). To date, the device has not been returned. If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form. 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. Can you clarify which hcp applied the product (surgeon, pa or assistant)? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? was prineo 60 used on the left axilla incisions? was the patient exposed to similar products, such as artificial nails?.

Event Description

It was reported that a patient underwent a double mastectomy procedure on (b)(6) 2019 and topical skin adhesive was used. On (b)(6) 2019, the patient presented with severe blistering. Antihistamine was tried to address the issue, however this did not resolve the issue. The patient was prescribed steroids, and this alleviated the condition. Additional information was requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM -US
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8388716
• MDR Text Key: 137795001
• Report Number: 2210968-2019-79243
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/04/2019 Patient Sequence Number: 1