MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED 0.7ML - 12EA; ADHESIVE, TOPICAL SKIN

Catalog Number DNX12

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint#: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: coordinator advised that surgeon complained about a skin reaction with dermabond advanced from a patient after seeing the patient at their post op visit.According to the surgeons pa the surgeon will be stopping use.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? unknown, patient status/ outcome / consequences yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? skin reaction, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, if yes, describe? skin reaction , is the patient part of a clinical study? unknown, additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Some patients received benadryl and/or topical ointment and prednisone for severe reactions.What is the procedure name? unknown.What is the procedure date? unknown but within the last couple of weeks.What date did the reaction occur on? unknown.What does the reaction look like and how large of an area does the reaction cover? unknown.Do you have any pictures of the reaction? no.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription medication)? if so, please specify.Unknown.If medication was required, please clarify if it was prescription strength.Unknown.Can you identify the lot number of the product that was used? unknown.What is the most current patient status? unknown.Was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown.Were any cultures taken? results? unknown.Please describe how was the adhesive was applied.Unknown.What prep was used prior to, during or after adhesive 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.Was patient screening done prior the procedure, e.G.Check patient not allergic to cyanoacrylate, formaldehyde, bac, pressure-sensitive adhesive? unknown.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 used or been exposed to similar glues/agents for repair, crafts, cosmetic use (lashes, nails)? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unknown.Is product available to return for analysis.No.The single complaint was reported with multiple events.There are no additional details regarding the additional events.No product available for return.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.

Event Description

It was reported a patient underwent an unknown procedure on an unknown date in 2023 and topical skin adhesive was used.Dr.Complained about a skin reaction with adhesive from a patient after seeing the patient at their post op visit.Treated with benadryl and/or topical ointment and prednisone for severe reactions.Additional information has been requested.

• Brand Name: DERMABOND ADVANCED 0.7ML - 12EA
• Type of Device: ADHESIVE, TOPICAL SKIN
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18097395
• MDR Text Key: 327698112
• Report Number: 2210968-2023-08667
• Device Sequence Number: 1
• Product Code: MPN
• UDI-Device Identifier: 10705031203532
• UDI-Public: 10705031203532
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152096
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DNX12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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