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 Visual Disturbances (2140); Post Operative Wound Infection (2446)

Event Date 11/10/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).H6.Health effect - impact code: f24 - specific prism glasses.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: acta neurochirurgica.165:3887¿3893.Https://doi.Org/10.1007/s00701-023-05872-4.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 : microvascular decompression for trigeminal neuralgia: a single-center experience with 516 cases, including 32 patients with multiple sclerosis author : nicolò castelli, niccolò innocenti, paolo ferroli, andrea saladino, giovanni broggi, irene tramacere, giovanni carone, vincenzo levi, michele rizzi, vittoria nazzi citations : acta neurochirurgica.165:3887¿3893.Https://doi.Org/10.1007/s00701-023-05872-4.The aim of this study was to evaluate the effectiveness and long-term pain relief of microvascular decompression (mvd) for ¿typical¿ trigeminal neuralgia (tn), including patients affected by multiple sclerosis (ms).Our study comprises data collected over 12 years, with 516 patients, 32 of whom had multiple sclerosis (ms) between january 2011 and january 2022,.Of these, 302 were females (58, 52%) and 214 males (41, 48%), with an average age of 59.37 (± 12.26).Once that the nerve was separated from the offending vessels, a non-compressive decompression technique was used in order to maintain the compressive vessels far from the nerve.To do so a combination of pieces of fibrillar oxidised cellulose (fibrillar surgicel®, ethicon, ohio) or free muscle fragments eventually fixed with fibrin glue were employed.The reported complication included diplopy (n=17), and wound infections (n=5).In conclusion, mvd may be considered an effective and safe surgical technique for tn, and in patients affected by multiple sclerosis, it may be proposed even if a less favorable outcome has to be expected with respect to classic tn patients.

• 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: 19201844
• MDR Text Key: 341269074
• Report Number: 2210968-2024-04939
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/29/2024

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: 04/16/2024
• Initial Date FDA Received: 04/29/2024
• 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