MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 22CM SKIN CLOSURE; SURGICAL SEALANT

Catalog Number CLR222US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested and obtained: initial procedure date.Surgery date 6/14 - noticed reaction on june 19th when ace wrap was removed by mother.How was the reaction treated (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify.Reaction was treated with antibiotics and steroids - pieces of product remained; too tough to remove without further irritating the skin.Please describe how was the adhesive applied on the tape.Proper application steps for use were followed.What prep was used prior to, during or after prineo use? chloroprep wash was used prior to draping the patient and was completely washed away and dried prior to using prineo.Was a dressing placed over the incision? if so, what type of cover dressing used? gauze and ace wrap was used over the prineo.Was the site cultured? if so, what bacteria were identified? don¿t believe the site was cultured.The nurse practitioner commented that she felt it ¿looked like a chemical burn¿.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? nurse practitioner reported no known allergies to any of the components in prineo.Is the patient hypersensitive to pressure sensitive adhesives? no pre-op allergy tests were performed that nurse practitioner is aware of.Were any patch or sensitivity tests performed? no pre-op allergy tests were performed that nurse practitioner is aware of.What is the physicians opinion of the contributing factors to the reaction? no comment was received from physician on contributing factors to the reaction.What is the most current patient status? no information provided.Is the product or representative sample (product from the same lot number) available for evaluation? no lot number is available for evaluation.Patient pre-existing medical conditions (ie.Allergies, history of reactions).No pre-existing medical conditions were noted.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure? this was the first experience with prineo for the patient.The nurse practitioner was concerned about how to get the remainder of the prineo off without using a vaseline (petroleum based product, or an acetone for fear of causing additional damage to the surrounding skin and wound.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an unknown knee surgery on (b)(6) 2019 and topical skin adhesive was used.On (b)(6) 2019, 5 days post operation, patient had a severe reaction to adhesive on patients left leg.Reaction was treated with antibiotics and steroids.Additional information was requested.

• Brand Name: DERMABOND PRINEO 22CM SKIN CLOSURE
• 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 PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8817153
• MDR Text Key: 151896180
• Report Number: 2210968-2019-84580
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133864
• 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
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2019
• 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
• Patient Age: 13 YR