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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT CUTANEOUS TISSUE ADHESIVE WITH MESH

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ETHICON, INC. ETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT CUTANEOUS TISSUE ADHESIVE WITH MESH Back to Search Results
Catalog Number MPH256
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Itching Sensation (1943); Skin Irritation (2076); Reaction (2414)
Event Date 01/17/2019
Event Type  Injury  
Event Description
It was reported that a pt underwent a surgical procedure for "total knee arthroplasty" on (b)(6) 2019 and prineo skin closing system was used. The pt developed a reaction to the product about 15-20 days after the procedure. The pt was reported and observed to have symptoms of redness, itching, and blisters to the skin directly adjacent to and around the prineo dressing. The topical skin adhesive was then removed. Anti-allergic med and local and systemic corticosteroids were given. Layer of sutures closed by the provider was combination of "#0 vicryl 2-0 vicryl, 3-0 v loc. " the angle of the knee during surgery was reported as flexed and greater than 80 degrees. Preparation before prineo use was 2% chg wipes the night before surgery and the morning before along with chloraprep x 2 used to prep the extremity in the operating room. No known allergies reported for pt with no patch or sensitivity tests performed. Fda safety report id# (b)(4).
 
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Brand NameETHICON, INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
Type of DeviceCUTANEOUS TISSUE ADHESIVE WITH MESH
Manufacturer (Section D)
ETHICON, INC.
somerville NJ 08876
MDR Report Key8991949
MDR Text Key158132210
Report NumberMW5089698
Device Sequence Number1
Product Code OMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 09/08/2019
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received09/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMPH256
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/10/2019 Patient Sequence Number: 1
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