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); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 01/01/2023

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: innovations 2023, vol.18(3) 276¿281; doi/10.1177/15569845231176291.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: the efficacy of bloodstop ix, surgicel, and gelfoam in vascular operations: first-in-human head-to-head study.Author(s): mosaad soliman, phd , khaled mowafy, phd, amr elshafae, md, nashaat elsaadany, md,and reem soliman, md.Citation: innovations 2023, vol.18(3) 276¿281; doi/10.1177/15569845231176291.This study aims to compare the efficacy and safety of 3 different hemostatic agents in vascular surgeries in humans.Between 2020 to 2021, 24 patients with 40 vascular anastomoses including 16 aortic and 24 femoral were included in the study.The patients were randomized (computer-based) to either 2 competitors' hemostatic agents (manufacturers: lifescience plus and pfizer) or surgicel (ethicon).There were 20 males and 4 females with a mean age of 57.20 ± 4.81 (range, 45¿63).After completion of the vascular anastomosis and securing the suture line, the hemostatic agent was then applied.Surgicel (ethicon) was applied to 2 aortic and 11 femoral anastomoses while the rest were applied with competitors¿ hemostatic agents.Reported complications included infection (n=2), wound dehiscence (n=3), secondary hemorrhage due to disruption of femoral anastomosis at 11 days postoperative (n=1).In conclusion, bloodstop ix is safe and effective for achieving vascular anastomosis hemostasis.Bloodstop ix dramatically reduced bleeding volume and time compared with the other hemostatic agents.Bloodstop ix showed a lower complication rate and did not interfere with the healing process at the application sites.

• 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.-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: 17996701
• MDR Text Key: 326395326
• Report Number: 2210968-2023-08121
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2023

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: 10/11/2023
• Initial Date FDA Received: 10/24/2023
• 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): Other