MAUDE Adverse Event Report: ETHICON INC. DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE; CUTANEOUS TISSUE ADHESIVE WITH MESH

Model Number CLR422US

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

Patient Problems Itching Sensation (1943); Local Reaction (2035)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure? date of reaction? please describe how the adhesive was applied.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? is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? is the patient hypersensitive to pressure sensitive adhesives? were any patch or sensitivity tests performed? patient demographics: initials / id, gender, age or date of birth; bmi patient pre-existing medical conditions (ie.Allergies, history of reactions) has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? was prineo skin adhesive used on the patient in a previous surgery or wound closure? what is the current status of the patient? no product to be returned.

Event Description

It was reported a patient underwent a total knee replacement procedure on an unknown date and topical skin adhesive was ued.Post op, the patient came in for their post op visit with itching, redness, and contact dermatitis.Treated with prescribed oral antihistamine, a topical steroid and removed the adhesive, when normally it would have stayed on.Bandage applied.Additional information has been requested.

Manufacturer Narrative

Product complaint#: (b)(4).Date sent to the fda: 5/25/2021.Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent date of procedure? unknown.Date of reaction? picture taken by (b)(6) on (b)(6) 2021.Please describe how the adhesive was applied.Per ifu.What prep was used prior to, during or after prineo use? unknown.Was a dressing placed over the incision? if so, what type of cover dressing used? unknown.Is the patient hypersensitive or have allergies to cyanoacrylate or formaldehyde? unknown.Is the patient hypersensitive to pressure sensitive adhesives? unknown.Were any patch or sensitivity tests performed? no.Patient demographics: initials / id, gender, age or date of birth; bmi.Unknown.Patient pre-existing medical conditions (ie.Allergies, history of reactions).Unknown.Has the patient previously been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.Was prineo skin adhesive used on the patient in a previous surgery or wound closure? unknown.What is the current status of the patient? unknown.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: DERMABOND PRINEO 42CM MSH 3.8ML ADHESIVE
• Type of Device: CUTANEOUS TISSUE ADHESIVE WITH MESH
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11778620
• MDR Text Key: 264491105
• Report Number: 2210968-2021-04251
• Device Sequence Number: 1
• Product Code: OMD
• UDI-Device Identifier: 10705031240421
• UDI-Public: 10705031240421
• Combination Product (y/n): N
• PMA/PMN Number: K163645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: Health Professional
• Device Model Number: CLR422US
• Device Catalogue Number: CLR422US
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 05/06/2021
• Supplement Dates FDA Received: 05/26/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention