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

Catalog Number MPH256

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Local Reaction (2035); Skin Irritation (2076); Skin Inflammation (2443)

Event Date 03/25/2019

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 6 days after the procedure.The pt was reported and observed to have symptoms of redness, itching, and blisters to the skin directly at and around the site of the prineo dressing.The topical skin adhesive was then removed.The pt was medicated with silvadene cream on (b)(6) 2019.Layer of sutures closed by the provider was combination of "#1 polysorb, 0 v-loc, 0 polysorb, 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 patch or sensitivity tests performed.Fda safety report id# (b)(4).

• Brand Name: PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON, INC. ; somerville NJ 08876
• MDR Report Key: 8991499
• MDR Text Key: 157834219
• Report Number: MW5089687
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• 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 Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MPH256
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR