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); Abscess (1690); Unspecified Infection (1930); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 10/12/2022

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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number(s).Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative patient consequences described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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? did surgiflo caused any of the reported adverse events described in the article? if yes, please elaborate on the cases.Citation: gynecologic oncology reports 44 (2022) 101085; https://doi.Org/10.1016/j.Gore.2022.101085 event related to mw number 2210968-2023-03537, importer report number 2210968-2023-100004 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: evaluating the risk of post-operative abscess formation following use of hemostatic agents at time of hysterectomy.Author(s): megan howard, jeanine n.Staples, samhita nelamangala, connell kling, linda r.Dusk.Citation: gynecologic oncology reports 44 (2022) 101085; https://doi.Org/10.1016/j.Gore.2022.101085.The primary study objective was to determine if intraoperative use of hemostatic agents (ha) was associated with postoperative abscess formation in patients undergoing hysterectomy.Between january 1, 2019 and december 31, 2019, 428 women who underwent hysterectomy over the one-year period were included in the study.The average age was 58 years (range 29¿95 years) and average bmi was 34 kg/m2 (range 18¿64kg/m2).Endometrial cancer was the most common indication for hysterectomy (188 patients).A hemostatic agent was used in the majority of cases (246 patients).The most commonly used agent was surgicel powder (ethicon) in 160 patients, followed by by surgicel snow (ethicon) in 28 patients and surgiflo (ethicon) in 27 patients.More than one agent was used in 14 patients.The reported complications included pelvic abscess (n=12), small bowel obstruction or ileus (n=5), vulvar edema (n=1), surgical site infection (n=1), vaginal cuff dehiscence (n=1) and 7 cm vaginal cuff abscess as well as a sub-umbilical abscess from prior laparoscopic incision site (n=1).In conclusion, no association was found between hemostatic agent use and abscess formation; however, data showed hemostatic agent use was associated with increased odds of presentation to the emergency department and readmission to the hospital within 30 days of surgery.Given the potential negative impact on patient outcomes, use of these products at time of hysterectomy should be made with careful consideration.

• 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: 16913274
• MDR Text Key: 315025994
• Report Number: 2210968-2023-03539
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2023

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: 05/02/2023
• Initial Date FDA Received: 05/11/2023
• 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 Sex: Female