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

Catalog Number CLR602US

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 09/28/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.How was the dermabond applied? dermabond liquid was applied in a thin layer on top of the skin (for dnx12) and on top to the tape(for clr602us).Excess liquid is wiped off the patient¿s skin.What layer of tissue was the dermabond applied to? dermabond was applied to the epidermis of the patient (for dnx12) and on top of the tape (for clr602us).How many layers of dermabond were applied? one.How was the prineo applied on the mesh? not fully understanding this question but if asking how was the liquid portion of the prineo applied to the mesh tape, it was applied in one thin layer.What prep was used prior to product application? chloroprep.Was a dressing placed over the incision? if so, what type of cover dressing used? no dressings on small incisions.Large abdominal incisions sometimes get abdominal binders.What date did the reaction occur on? reaction occurred (b)(6) 2018; what does the reaction look like and how large of an area does the reaction cover? the reaction is yellowish and rash-like.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? for case (b)(6) 2018, doctor was seeing and treating patient three times a week.The rash became less severe on (b)(6) 2018 but still appeared yellowish and rash-like.Can you identify the product code and lot number of the product that was used? codes were dnx12 and clr602us.No lot numbers were recorded.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? not certain if patient is allergic to the aforementioned.Patient demographics: initials/id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) ¿ patient is female.

Event Description

It was reported that a female patient underwent a plastic surgery procedure on (b)(6) 2018 and topical skin adhesive was used.The patient experienced a severe skin reaction which is yellowish and rash-like.The patient was seeing the doctor and was being treated three times a week.The rash became less severe on (b)(6) 2018 but still appeared yellowish and rash-like.Additional information was requested.

Manufacturer Narrative

Product complaint # : (b)(4).Additional information was requested and the following was obtained: do you have photos for the patient procedure date (b)(6) 2018 and patient procedure date (b)(6) 2017? no other photos do you have event dates or details for any additional patient events? no further information please describe where the dermabond and prineo 60 were used on each patient? yes, both were used on patient, but on different sections of the patient.Where specifically was the prineo 60 used on the patient? used on higher tension area panniculectomy section.Where was the dnx12 used on the patient? used on smaller incisions, used for the breast portion.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM -US
• 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; road 183, km. 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8093366
• MDR Text Key: 128031224
• Report Number: 2210968-2018-77270
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention