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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
Catalog Number PRINEOUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cellulitis (1768); Itching Sensation (1943); Rash (2033); Skin Irritation (2076)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Attempts to obtain the following information have been made with no response to date. If further details are received at a later date a supplemental medwatch will be sent. Can you clarify the exact number of patients with reaction and provide demographics/ dates? do you have any photos? can you provide the product code for the prineo? what was the name of the initial procedure on the male patient? what was the date of the procedure? how was the prineo adhesive applied to the mesh? how many layers of adhesive were used on the mesh? what prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur post op? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? were any patch or sensitivity tests performed? what is the physician¿s opinion of the contributing factors to the reaction? patient demographics: initials / id; age or date of birth; bmi; medical history patient pre-existing medical conditions (ie. Allergies, history of reactions) was prineo/ demabond or skin adhesive used on the patient in a previous surgery or wound closure? what is the most current patient status? to date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported a patient underwent an unknown orthopedic procedure on an unknown date in 2019 and topical skin adhesive was used. Patient had post op reaction to area around topical skin adhesive, it is red and rashed, with a raised area, cellulitic, during a follow up appointment. Underneath the mesh, red/itchy. They have prescribed antibiotics.
 
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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 0151
Manufacturer (Section G)
ETHICON INC.-SAN LORENZO PR
road 183, km. 8.3
san lorenzo 00754
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8452785
MDR Text Key139880901
Report Number2210968-2019-79669
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 Nurse Practitioner
Type of Report Initial
Report Date 02/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPRINEOUNK
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/25/2019
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: 03/26/2019 Patient Sequence Number: 1
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