MAUDE Adverse Event Report: ETHICON INC. SURGICEL ABSORBABLE HEMOSTAT UNKNOWN; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Seroma (2069); Impaired Healing (2378); Thromboembolism (2654)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned.This report is related to a journal article, therefore no product will be returned for analysis and the manufacturing record evaluation cannot be reviewed as the lot number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).2.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? 3.Does the surgeon believe there was any deficiency with the ethicon products used in this procedure? 4.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.5.Can specific patient demographics: initials; age or date of birth; bmi; gender; patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates of study drugs be provided? citation: aesth plast surg.2023; https://doi.Org/10.1007/s00266-023-03748-7.Event related to uf/importer report number: 2210968-2024-100014.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 a journal article: title: hemostatic agents do not significantly affect seroma formation in abdominal body contouring.Authors: hayeem l.Rudy1 ¿ peter shamamian1 ¿ julia grande1 ¿ fei wang1 ¿ yi-hsueh lu1 ¿ joseph a.Ricci1,2.Citation: aesth plast surg.2023; https://doi.Org/10.1007/s00266-023-03748-7.The aim of this retrospective study was to investigate the association between hemostatic agent usage and seroma development following abdominal body contouring surgery (abcs).Between january 2010 and march 2020, a total of 707 patients (50 male and 645 female; mean age of 45.1 years) who underwent abdominoplasty and panniculectomy were included in the study.Among these, 104 patients who were not treated with intraoperative hemostatic agents were matched to 65 case patients who received hemostatic agents.Hemostatic agents included surgicel (ethicon) in 6 patients, evicel (ethicon) in 7 patients, surgifoam (ethicon) in 2 patients, while the rest of the patients uses competitor devices.Reported complications include seroma (n=?), hematoma (n=?), venous thromboembolism (n=?), delayed wound healing (n=?), and wound dehiscence (n=?).In conclusion, hemostatic agent use, regardless of type, does not significantly affect the risk of seroma, hematoma, and venous thromboembolism development, nor does it influence the rates of delayed wound healing or wound dehiscence.

• Brand Name: SURGICEL ABSORBABLE HEMOSTAT UNKNOWN
• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19161026
• MDR Text Key: 340802991
• Report Number: 2210968-2024-04744
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N12159
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/22/2024
• 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): Other