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); Meningitis (2389); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

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.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? was there any medical or surgical intervention performed (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed)? if so, please clarify.Can you identify the product code and lot number of the product that was used in each procedure? can specific patient demographics initials / id; 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? event related to mw #: 2210968-2021-07995, 2210968-2021-07997, 2210968-2021-07999, and 2210968-2021-08000.Citation:european annals of otorhinolaryngology, head and neck diseases 137 (2020) 477¿481, https://doi.Org/10.1016/j.Anorl.2019.10.003.

Event Description

It was reported via a journal article: title: endonasal endoscopic oncologic resection and reconstruction of the anterior skull base in the elderly: a single-center retrospective study.Authors: e.Chabrillaca, g.De bonnecazea, m.Rivesb, v.Lubranoc, e.Serranoa, s.Vergeza citation:european annals of otorhinolaryngology, head and neck diseases 137 (2020) 477¿481, https://doi.Org/10.1016/j.Anorl.2019.10.003.The aim of the present study was to assess functional and oncologic results after endonasal endoscopic anterior skull-base resection of sinonasal tumor in over-70 year-olds.October 2018 included all patients aged over 70 years undergoing malignant sinonasal tumor resection with partial or total resection and reconstruction of the anterior skull base on an endonasal approach.Anterior skull-base resection was indicated on imaging and/or intraoperative findings.Resection followed castelnuovo¿s technique, always removing a layer of healthy tissue to guarantee safe margins: resection of cribriform plate in case of olfactory cleft mucosal involvement, of meninx in case of bone involvement, and of cerebral parenchyma in case of meningeal involvement.According to defect size, reconstruction associated surgicel (ethicon).Reported complications reported: patient 1: a (b)(6) years old male with rhinoliquorrhea and local progression, meningitis.Patient 2: a (b)(6) years old female experienced with radiation induced ophthalmoplegia , meningitis and local progression.Patient 7: a (b)(6) years old male with local progression.Patient 10: a (b)(6) years old male with rhinoliquorrhea.Patient 13: a (b)(6) years old male local and metastatic.In conclusion this technique is a feasible treatment in patients aged over 70 years, providing good functional results, and acceptable oncologic outcome.

• 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
• MDR Report Key: 12418964
• MDR Text Key: 269786138
• Report Number: 2210968-2021-07996
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2021

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: 08/19/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR