MAUDE Adverse Event Report: ETHICON INC. DERMABOND ADVANCED UNKNOWN PRODUCT; ADHESIVE, TOPICAL SKIN

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).Additional information: h6 component code: g07002 - device not returned additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that any of the ethicon products involved dermabond advanced unknown caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon product / dermabond advanced unknown used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: doi: 10.1111/ajd.12858 , attached.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 via journal article: title: contact dermatitis to dermabond advance the aim of the study was to determine the allergic reaction of the dermabond advanced.Several formulations have been marketed since 1999, including dermabond advance.The identified 18 previous publications describing dermabond allergic contact dermatitis, the first in 2008.A 39 years old woman underwent a laparoscopic cholecystectomy.One week after the surgery, she developed dermatitis at the port site that had been closed with dermabond advanced (ethicon).Reported complication is persistent dermatitis.In conclusion, it is important to be aware of the possibility of allergic contact dermatitis from surgical cyanoacrylate adhesives that may persist for many weeks and may result in autoeczematization.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.No further information will be provided because we can¿t get any additional information from the author.Does the surgeon believe that any of the ethicon products involved dermabond advanced unknown caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon product dermabond advanced unknown used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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 UNKNOWN PRODUCT
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18751799
• MDR Text Key: 335902885
• Report Number: 2210968-2024-01637
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Female