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

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

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Fluid Discharge (2686); Blister (4537)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: component code: g07002 - device not returned.As no contact information has been provided, no follow up can or will be performed at this time.If further details are received at a later date a supplemental medwatch will be sent.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: british society for cutaneous allergy, vol.185, pages 1-1 (uk) journal article 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: two cases of follicular allergic contact dermatitis following the use of cyanoacrylate surgical glue a case of a 42-year-old woman who developed a pruritic follicular rash with associated discharge at the portal sites 3 days after her laparoscopic gastric band removal the rash was present around the portal sites, extending more widely around the sites where dermabond (ethicon) surgical glue (2- octylcyanoacrylate) had been used.She was treated with flu­cloxacillin, with little benefit.She had a history of previous laparoscopic surgeries for cholecystectomy and appendectomy, with primary closures of the portal sites with sutures only.Examination revealed erythe­matous follicular papules adjacent to the scar.Patch testing to the bsca standard and acrylate series showed positive reac­tions to dermabond.In conclusion, this also highlights the importance of testing to the patient's own products as there is currently only one cyanoacrylate, ethyl cyanoacrylate.

• Brand Name: DERMABOND 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 PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18601959
• MDR Text Key: 334024030
• Report Number: 2210968-2024-00742
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/05/2024
• 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: 42 YR
• Patient Sex: Female