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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); Rash (2033); Not Applicable (3189)
Event Date 09/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). The following information has been requested but not received. To date the device has not been received. If the further details are received at a later date a supplemental medwatch will be sent. What is the name of your surgeon? does ethicon have your permission to contact your surgeon, in the event we would like to for more clinical information to be used for a product quality investigation? if so, please sign and return the attached form and provide your surgeon's contact email and information.
 
Event Description
It was reported a patient underwent a thyroidectomy on (b)(6) 2020 and topical skin adhesive was used. Two days post operatively, the patient developed a very red and itchy reaction. The site was leaking a light-yellow fluid. Patient had rash around the wound, chest to chin. It was suggested to remove the adhesive with vaseline with a cotton swab. Applied zinc ointment and hydrocortisone. The patient was given a steroid. Additional information has been requested.
 
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Brand NamePRINEO SKIN CLOSURE SYSTEM UNKNOWN PRODUCT
Type of DeviceSURGICAL SEALANT
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
elba bello
p.o. box 151, route 22 west
somerville, NJ 08876
9082183429
MDR Report Key10673366
MDR Text Key211279467
Report Number2210968-2020-07948
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received01/19/2021
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: 10/13/2020 Patient Sequence Number: 1
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