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 Hypersensitivity/Allergic reaction (1907); Rash (2033)

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.The following additional information was provided: were the antihistamine or hydrocortisone cream prescribed? yes did the patient experience a post-op device malfunction? no, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing?unknown, did the patient require revision surgery or hardware removal? no, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? a rash appeared in the location where the prineo was placed, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: no, is the patient part of a clinical study unknown, ip-00486232 device property of none, device in possession of none.Attempts are being made to obtain the following information.However, no further information is available: what is initial procedure date? what date did the reaction occur on? do you have any pictures of the reaction? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.What is the most current patient status? can you identify the lot number of the product that was used?.

Event Description

It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used.The patient developed a latent rash reaction approximately 4-6 weeks after surgery, in the same location where the topical skin adhesive was placed.The topical skin adhesive had sloughed off or had been removed, but in that location, rash-like vesicles were seen.The reaction spreads a bit throughout the leg.The rash resolved on its own within about a week and did not require any major intervention other than antihistamine and hydrocortisone cream.There has been no change in patient prep nor their pre-op medications.Additional information has been 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; 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: 8380731
• MDR Text Key: 137508979
• Report Number: 2210968-2019-79169
• 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: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• 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