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

Catalog Number CLR222

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

Patient Problems Wound Dehiscence (1154); Erythema (1840); Skin Irritation (2076)

Event Date 10/02/2018

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What is the initial procedure date? how was the prineo applied on the mesh? what prep was used prior to product application? what was the location and incision size of the application? was a dressing placed over the incision? if so, what type of cover dressing used? 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.Can you identify the lot number of the product that was used? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? if the patient is female, please ask if they were exposed to similar products, such as artificial nails? what is the most current patient status? patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was used.Postoperatively, on (b)(6) 2018 the patient experienced a significant reaction with redness and wound breakdown all along the dressing site.The patient had an allergy to chlorhexidine.Additional information has been requested.

Manufacturer Narrative

Product complaint # pc-(b)(4).Additional information was requested and the following was obtained: did the surgeon use chlorhexidine for this procedure or another product in place of for prep ? no used betadine how was the prineo applied on the mesh? a thin layer using applicator provided what type of cover dressing used? hyperfix then honeycomb was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Removed the dermabond prineo can you identify the lot number of the product that was used? no is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? only known allergies chlorhexidine what is the most current patient status? current status is skin is now all clear and wound all healed patient demographics: initials / id; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions) (b)(4).¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? no.

• Brand Name: DERMABOND PRINEO 22CM
• 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: 8003370
• MDR Text Key: 124961002
• Report Number: 2210968-2018-76761
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K133864
• 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,Followup
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: CLR222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/24/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/02/2018
• 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