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); Unspecified Infection (1930)

Event Date 12/21/2021

Event Type  Injury  

Event Description

It was reported via journal article: title: wound dehiscence following cubital tunnel surgery.The purpose of the present study was to specifically evaluate the incidence of, and risk factors for, wound dehiscence after simple decompression and transposition.Between january 1, 2016 and december 31, 2019, 1401 patients who underwent ulnar nerve surgery were included in the study.There were 295 patients identified who underwent transposition and 1,106 patients who underwent simple decompression.40 percent of the patients were females.The mean age of the entire cohort was 56 years (range, 13 to 92 years), and the mean bmi was 30 kg/m2 (range, 14 to 55 kg/2).Deep closure materials included monocryl suture (ethicon) in 152 patients, and vicryl in 376 patients (ethicon) while others did not use any sutures.Subcutaneous closure material included monocryl suture (ethicon) in 505 patients, prolene suture (ethicon) in 172 patients, vicryl suture (ethicon) in 237 patients, non-ethicon nylon (manufacturer: unknown) in 330 patients and no closure materials for 157 patients.Skin closure included dermabond (ethicon) or a competitor steri (manufacturer: unknown) in 221 patients, monocryl suture (ethicon) in 184 patients, and prineo (ethicon) in 42 patients, non-ethicon' devices such as benzoin, nylon, steri, staples (manufacturers: unknown) in some patiens and 666 patients used none.Reported complications included wound dehiscence (n=29) and surgical site infection (n=?).In conclusion, wound dehiscence can occur following both simple decompression and transposition, even after postoperative evaluation demonstrates a healed wound.Surgeons should be aware of this possibility and specifically counsel patients about remaining cautious with, and protective of, their wound for several weeks after surgery.Dehiscence may be related to suboptimal vascularity in the soft tissue envelope in the posteromedial elbow.When it occurs, dehiscence can generally be treated by allowing healing by secondary intention.

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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that any of the ethicon products involved (monocryl, vicryl, prolene sutures, dermabond) caused and/or contributed to the post-operative complications: wound dehiscence, surgical site infection, described in the article? does the surgeon believe there was any deficiency with any of the ethicon products (monocryl, vicryl, prolene sutures, dermabond) used in this procedure? if so, please provide details.Which specific ethicon products (monocryl, vicryl, prolene sutures, dermabond) have been used during the procedures (product code, lot number)? patient demographics? the single complaint was reported with multiple events.There are no additional details regarding the additional events.No product available for return.Note: events reported via: mw# 2210968-2024-01916, mw# 2210968-2024-01917, mw# 2210968-2024-01918.Citation: citation: j hand surg am.2023;48(6):622.E1-e7; https://doi.Org/10.1016/j.Jhsa.2021.12.012.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 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 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18787248
• MDR Text Key: 336293819
• Report Number: 2210968-2024-01919
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/02/2024
• 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