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

Catalog Number CLR222

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Skin Irritation (2076)

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.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.How was the prineo applied on the mesh? what prep was used prior to product application? was a dressing placed over the incision? if so, what type of cover dressing used? what date did the reaction occur on? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.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 (b)(6) 2018 and topical skin adhesive was used over the incision.The patient developed a skin reaction with possible contact dermatitis.The surgeon has been using the topical skin adhesive for three years with no previous issues.The dermatologist report indicates that there may be environmental factors involved such as dry conditions.Additional information has been requested.

Manufacturer Narrative

Product complaint # pc-(b)(4).A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.Additional information was requested and the following was obtained: patient had prineo applied prior to the reported procedures? where the patients have had a prior procedure the surgeons believe that it is highly likely that prineo would have been used as they have been using prineo routinely for over 3 years - how were the reactions treated/resolved? information has not been provided - lot/batch? we have not been able to confirm ¿ how was the prineo applied on the mesh? as per ifu ¿ what prep was used prior to product application? incision and surrounding area wiped with chlorhexidine and then dried with a second pack ¿ what type of cover dressing used? a honeycomb tegaderm dressing is placed over the prineo then webril and a crepe bandage to finish.¿ is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? currently being assessed by dermatologist ¿ patient pre-existing medical conditions (i.E.Allergies, history of reactions)- nothing additional to original report.

• 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 PR; 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: 7930402
• MDR Text Key: 122509522
• Report Number: 2210968-2018-76269
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CLR222
• Device Lot Number: MDQ377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention