MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM; SURGICAL SEALANT

Catalog Number CLR422US

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

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

Event Date 09/20/2018

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: how was the prineo applied on the mesh? prineo was applied as per ifu.What prep was used prior to product application? chlorhexidine was used at beginning of procedure but knee was cleaned and dried prior to application.Was a dressing placed over the incision? if so, what type of cover dressing used? no dressing used.Was the topical skin cream used to treat the reaction prescribed? that is my understanding.Used after prineo was removed.Can you identify the lot number of the product that was used? no.All discarded as there was no indication that there would be complications.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Was the patient exposed to similar products, such as artificial nails? unknown.What is the most current patient status? patient has recovered well.Patient demographics: initials / id; age or date of birth; bmi; patient pre-existing medical conditions (i.E.Allergies, was prineo or skin adhesive used on the patient in a previous surgery or wound closure? no.

Event Description

It was reported that a patient underwent a total knee arthroplasty procedure on an unknown date and topical skin adhesive was applied to the knee closure.Eight days post op on (b)(6) 2018, the patient returned with a significant rash under and around the topical skin adhesive.The surgeon removed the topical skin adhesive and treated with topical skin cream.It was opined that the patient was allergic to the topical skin adhesive.Additional information has been requested.

• Brand Name: DERMABOND PRINEO 42CM
• 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; 982 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: 7993570
• MDR Text Key: 124662409
• Report Number: 2210968-2018-76695
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031240421
• UDI-Public: 10705031240421
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR422US
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention