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 Hypersensitivity/Allergic reaction (1907)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a robotic hiatal hernia on (b)(6) 2023 and topical skin adhesive was used.Patient had an allergic reaction following a procedure from adhesive usage.3-4 days post-op.Treated with prescribed steroids.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.¿ what is the procedure name? robotic hiatal hernia ¿ what is the procedure date? (b)(6) 2023.¿ what date did the reaction occur on? day 3-4 ¿ 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.Yes, prescribed steroids ¿ if medication was required, please clarify if it was prescription strength.Unknown ¿ can you identify the lot number of the product that was used? no ¿ what is the most current patient status? surgeon said steroids cleared it up ¿ was prineo/dermabond or skin adhesive used on the patient in a previous surgery or wound closure? unknown was any surgical intervention performed? prescribed steroids to patient when they found out about reaction.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? it was a surprise to the surgeon from his years of using dermabond where they have never experienced the post-op reaction issue as much as it has been recently.No product available for return.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.

• 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: 18236072
• MDR Text Key: 329318308
• Report Number: 2210968-2023-09290
• 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: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• 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: 11/03/2023
• 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