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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 11/14/2018

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.Additional information was requested and the following was obtained: what is the initial procedure date? (b)(6) 2018.What date did the reaction occur on? first noticed at review (b)(6) 2018.What does the reaction look like and how large of an area does the reaction cover? rectangular area corresponding to prineo dressing.Do you have any pictures of the reaction? no was there any medical or surgical intervention performed - readmission to hospital for wound dressings.What is the most current patient status? wound healed and doing well.

Event Description

It was reported that a patient underwent a total knee replacement procedure on (b)(6) 2018 and topical skin adhesive was used.On (b)(6) 2018 the patient noticed a reaction to the topical skin adhesive.The reaction covered a rectangular area corresponding to the topical adhesive dressing.This was the first time that the topical skin adhesive was used on the patient.The skin prep was chlorhexidine.The patient was readmitted to the hospital for wound dressings.The wound healed and the patient is doing well.Additional information was requested.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO; 982 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 Key: 8384682
• MDR Text Key: 137668710
• Report Number: 2210968-2019-79194
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2019
• Initial Date FDA Received: 03/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention