MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/10/2022.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events citation: china continuing medical education, vol 13 no.33:127-130.Doi: 10.3969/j.Issn.1674-9308.2021.33.034.

Event Description

Title: to analyze the effect of hysteroscopic submucosal myoma resection.The aim of this study is to analyze the effect of hysteroscopic submucosal myoma resection.A total of 60 patients with submucous myoma of uterus from october 2019 to august 2020 were randomly divided into experimental group and control group according to random number table method, 30 cases in each group.The control group (n=30; mean age of 35.36 ± 1.75 years) was treated with laparoscopic resection of submucous myoma of uterus, while the experimental group (n=30; average age of 35.56 ± 1.48 years) was treated with hysteroscopic electrotomy, treatment and postoperative complications were compared.Under intravenous general anesthesia, pneumoperitoneum was established by conventional puncture, oxytocin was injected between the fibroid and muscle wall (the fibroid had been located by ultrasound before surgery), the tumor nucleus was incised deep from the surface of the tumor with a single-stage electric hook, the tumor was separated, the tumor was stripped, the uterine wall incision was divided with "0" johnson & johnson suture, and the serosa was continuously sutured (attention was paid to drainage tube was placed to observe whether there was exudation in the uterine incision.Reported complications include bleeding (n=5), infection (n=2), uterine fluid (n=1), thrombus (n=1), and invalid outcome (n=9).In conclusion., the implementation of hysteroscopic resection for patients with submucous myoma of uterus has significant effect, not only to improve the treatment effect, but also to reduce the incidence of complications has a positive significance.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• 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: 15569968
• MDR Text Key: 301510209
• Report Number: 2210968-2022-08293
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2022
• 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