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 Bruise/Contusion (1754); Purulent Discharge (1812); Inflammation (1932); Scarring (2061); Not Applicable (3189)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information received: what is the most current patient status? progressed to resolution but still experienced marked scaring.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Patient has strong history of allergic reactions to chlorhexidine, penicillin, tetanus, msaids and bandages.What is the physicians opinion of the contributing factors to the reaction? surgeon believes to be a prineo reaction.Attempts have been made to obtain the following additional information, however not received to date: t was noted that antibiotics were prescribed and readmitted for wound management, was the reaction treated in any other manner (product removed; reoperation; reclosure; other prescription)? if so, please clarify.Please indicate any medical or surgical interventions performed.Please describe how was the adhesive was applied on the tape.What prep was used prior to, during or after prineo use? was a dressing placed over the incision? if so, what type of cover dressing used? attempts have been made to obtain additional information.To date the device has not been returned and no additional information has been received.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 replacement on (b)(6) 2019 and topical skin adhesive was used.On post op day 3, patient presented with marked skin reaction at the surgical site: inflammation, blisters, bruising and wound discharge.Was re-admitted to hospital for antibiotics and manage wound and reduce surgical site infection risk.Progressed to resolution but still experienced marked scaring.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).The following information was requested and the following was obtained: what prep was used prior to, during or after prineo use? betadine (povidone-iodine), or chlorhexidine? chlorhexidine was a protective, dry wound dressing such as gauze applied and was it applied only after the liquid topical skin adhesive has completely polymerized and the dermabond¿ prineo¿ is no longer tacky to the touch? no was the application site cleansed thoroughly with saline or isopropyl alcohol to remove any remaining blood, fluids, or topical medications/anaesthetics, including skin preps, and then patted dry? yes were any patch or sensitivity tests performed prior to the procedure? no what is the most current patient status? reaction fully resolved.Good cosmetic outcome.Were any iv steroid/topical steroid/oral steroid/other treatments used to manage the reaction? antibiotics and steroid cream.Followed by vitamin e oil to reduce scar.Who applies the product? the surgeon himself? surgeon only & very experienced user with good technique aligned to ifu.If the reaction is on the knee, was the product applied while knee was extended or flexed? fully flexed.

• 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
• MDR Report Key: 8846765
• MDR Text Key: 152810619
• Report Number: 2210968-2019-84933
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031237339
• UDI-Public: 10705031237339
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: CLR222
• Device Lot Number: MHH085
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 63