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U.S. Department of Health and Human Services

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

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ETHICON INC. PRINEO SKIN CLOSURE SYSTEM -US SURGICAL SEALANT Back to Search Results
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.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM -US
Type of DeviceSURGICAL 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 Key8388716
MDR Text Key137795001
Report Number2210968-2019-79243
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 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 Received03/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCLR602US
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 Received04/17/2019
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
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