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

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

Patient Problems Failure to Anastomose (1028); Adhesion(s) (1695); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Obstruction/Occlusion (2422); Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Event Description

It was reported via a journal article: title: exploring adverse events and utilization of topical hemostatic agents in surgery authors: katherine a.O¿hanlan, md, paul bassett citation cite: doi: 10.4293/jsls.2022.00033 this retrospective study provides preliminary qualitative assessment of the adverse events (aes), focusing on pelvic and abdominal aes and patient outcomes reported for three hemostatic agents used in gynecologic surgery.Utilization rates for oxidized regenerated cellulose powder (orc), polysaccharide powder (psp), and fibrin sealant solution (fss) were obtained from hospitals via the premier healthcare databases for all surgical procedures from january 1, 2018 to september 30, 2020.All reported cases were extracted from the food and drug administration (fda) manufacturer and user facility device experience (maude) database for orc and psp and from the fda adverse event reporting system (faers) database for fss.Distributions of aes by anatomical site (maude/faers) and surgical procedures by specialty (premier) were evaluated for each product.Number of cases and number and types of aes were compared to the total utilization for each product.Orc (surgicel powder absorbable hemostat, ethicon, raritan, nj, usa) was utilizedin 129 patients.Reported complications included infection, required intervention,deep tissue/application site reaction , skin/wound problem, inflammation, allergic condition, skin hemorrhage, adhesions; fistula; gastrointestinal anastomotic leak; gastrointestinal inflammation; intestinal obstruction in conclusion this retrospective analysis suggests that orc use in pelvic and abdominal surgery may lead to increased aes compared with non-orc hemostatic agents.No causal relationship between use of these products in gynecologic surgeries and the occurrence of pelvic aes can be established with the available data.Further prospective randomized studies are needed to explore the safety and suitability between orc and nonorc products in gynecologic surgeries.

Manufacturer Narrative

Product complaint #: (b)(4).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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.6.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 cite: doi: 10.4293/jsls.2022.00033 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.

Manufacturer Narrative

Product complaint # (b)(4).The journal article pdf has been attached to this supplemental report as it was not included in the initial medwatch submission.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: SURGICEL POWDER DEVICE
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16766078
• MDR Text Key: 313560535
• Report Number: 2210968-2023-02805
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 04/18/2023
• 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): Life Threatening