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

Catalog Number CLR602US

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Rash (2033)

Event Date 07/27/2018

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 procedure name and initial procedure date? (b)(6) 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? there was a severe rash.Was there any medical or surgical intervention performed - patient was sent to a dermatologist for treatment.Her rash cleared and was resolved on (b)(6) 2018.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 was female.

Event Description

It was reported that a female patient underwent a plastic surgery procedure on (b)(6) 2018 or (b)(6) 2018 and topical skin adhesive was used.The patient experienced a severe rash which occurred (b)(6) 2018.The patient was sent to a dermatologist for treatment.The patients rash cleared and was resolved on (b)(6) 2018.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to fda: 12/6/2018.Additional information was requested and the following was obtained: do you have photos for the patient procedure date (b)(6) and patient procedure date (b)(6) ? 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
• MDR Report Key: 8090502
• MDR Text Key: 127939567
• Report Number: 2210968-2018-77250
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031024168
• UDI-Public: 10705031024168
• Combination Product (y/n): N
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR602US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2018
• Patient Sequence Number: 1
• Treatment: DNX12; DNX12
• Patient Outcome(s): Required Intervention