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

Catalog Number CLR222US

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cellulitis (1768); No Code Available (3191)

Event Date 05/22/2018

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.Please provide photos, initial procedure date, what date did the reaction occur post op? was the site cultured? if so, what bacteria were identified? what medical or surgical intervention was performed (product removed; reoperation; reclosure; prescription steroids; antibiotics prescribed)? if so, please clarify was there any wound dehiscence? please provide doctors opinion on the reason that the prineo started to lift off and how many days post op did the event occur? was the prineo removed prematurely or reapplied? if yes, please.What prep was used prior to, during or after prineo use? do you have the lot number involved.What is the physicians opinion of the contributing factors to the reaction? what is the most current patient status? is the product or representative sample (product from the same lot number) available for evaluation? patient demographics: initials / id; age or date of birth; bmi ; gender.Patient pre-existing medical conditions (ie.Allergies, history of reactions.) for female patients ask: was the patient exposed to similar products, such as artificial nails.Was prineo/demabond or skin adhesive used on the patient in a previous surgery or wound closure?.

Event Description

It was reported that a patient underwent a third time revision to a total knee replacement procedure on an unknown date and topical skin adhesive was used to close the wound.The patient has metal allergies.Within twenty-four hours of the topical skin adhesive being applied the wound was dressed with aquacel (ionic silver based dressing).The topical skin adhesive started to lift off and the wound started to drain.The patient developed cellulitis and has been in the hospital for ten to twelve days.It is unsure what was the cause of the cellulitis.Additional information has been requested.

Manufacturer Narrative

Product complaint #
=
> pc-000206886 date sent to fda: 7/23/2018 corrected information:- additional information received that indicates this event does not meet reporting serious injury criteria.This event therefore is not reportable.

• 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 PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7605036
• MDR Text Key: 111163489
• Report Number: 2210968-2018-73495
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031230996
• UDI-Public: 10705031230996
• Combination Product (y/n): N
• 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,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2018
• 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