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 Wound Dehiscence (1154); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 05/17/2023

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 (pds suture unk, monocryl suture unk, dermabond unk) caused and/or contributed to the post-operative complications described in the article (grade 3+ complications, superficial wound infections, dehiscence, reoperation, incisional hernia)? does the surgeon believe there was any deficiency with any of the ethicon products (pds suture unk, monocryl suture unk, dermabond unk) 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.Patient demographics? 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.Related events captured via: mw# 2210968-2024-00898, mw# 2210968-2024-00899 citation: surgery open science (2023);13:94¿98.Https://doi.Org/10.1016/j.Sopen.2023.05.002 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: low incisional hernia incidence using a large-bite, low-tension technique for celiotomy closure the aim of the study was to qualitatively assess incisional herniae (ih) rate and potentially contributing risk factors resulting from this standard technique.Between 2014 and 2021, a total of 336 patients (192 male and 144 female) who underwent primary incision closure after visceral resections were included in the study.The median age was 65 years (range: 17¿88 y) and 81% of patients had a cancer diagnosis.A continuous, single-layer, musculofascial mass closure with absorbable monofilament looped #1 pds suture with >2 cm bite and a stitch separation of at least 1.5 cm has been used for all open celiotomies including hand port sites.All 12 mm umbilical port sites were closed with 2 interrupted #0 pds figure-of-eight sutures, while 5 mm port sites through the muscular abdominal wall remained unclosed in the musculofascial layers.All incisions were then closed with intracutaneous (subcuticular) monofilament monocryl material, in 2¿0 size for major incisions, and 4¿0 size for port sites, followed by dermabond or steri-strip application and a sterile gauze dressing.Reported complications include grade 3+ complications (n=18.4%), superficial wound infections (n=3.7%), dehiscence requiring reoperation (n=1), and incisional hernia (n=11).In conclusion, the described technique leads to a low ih rate of <3 % in subcostal or midline incisions, and can be recommended for routine use.The observed results appear superior to those of the stitch trial, even for the smaller midline incision cohort.

• 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: 18630810
• MDR Text Key: 334495582
• Report Number: 2210968-2024-00900
• Device Sequence Number: 1
• Product Code: MPN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2024
• 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: 01/09/2024
• 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