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 Problem Rash (2033)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information was requested and received: date of the total knee replacement procedure? unknown.It was noted that both topical and oral steroids were administered, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify.Product removed before administering steroids.Please indicate any medical or surgical interventions performed.None.Please describe how was the adhesive was applied on the tape.Single layer with excess liquid wiped off after drying.What prep was used prior to, during or after prineo use? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? unknown.What is the physicians opinion of the contributing factors to the reaction? dr feels there has been a change in formulation or tape.What is the most current patient status? unknown.Is the product or representative sample (product from the same lot number) available for evaluation? no.Patient demographics: initials / id; age or date of birth; bmi; gender.Unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Unknown.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 a total knee procedure on an unknown date and topical skin adhesive was used.The patient returned to the doctor on (b)(6) 2019, complaining of a rash on and around the incision site.The doctor prescribed a topical and oral steroid to the patient.Patient currently okay.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 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: 8916957
• MDR Text Key: 155085859
• Report Number: 2210968-2019-85950
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• 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: 07/26/2019
• 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