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

Catalog Number CLR222US

Device Problem Biocompatibility (2886)

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Date 11/26/2018

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? (b)(6) 2018.How large of an area does the reaction cover? approximately 1 foot in length extending just medial to the incision to about 4 inches laterally.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify - the prineo along with the aquaseal dressing was removed.Steristripes were gently placed, and the patient was instructed to wash the area with soap and water.Two antibiotics were also prescribed for 10 days, keflex 500mg tid and bactrim ds.What is the most current patient status? after about 2 weeks the patient¿s skin cleared up and now he is doing well, with no issues.

Event Description

It was reported that a patient underwent a knee replacement procedure on (b)(6) 2018 and topical skin adhesive was used.Two and a half weeks post op the patient had a skin reaction that was bright red and blistered.The surgeon removed the topical skin adhesive, along with the aquaseal dressing.Steristrips were gently placed, and the patient was instructed to wash the area with soap and water.Two antibiotics were also prescribed for 10 days.After about two weeks the patient¿s skin cleared up and the patient is now doing well, with no issues.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; 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: 8265805
• MDR Text Key: 133709617
• Report Number: 2210968-2019-78532
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• 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: 01/17/2019
• 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