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); Itching Sensation (1943); Pain (1994); Swelling/ Edema (4577)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

(b)(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 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: clinical medical research and practice july 2022 volume 7, issue 21 // https://doi.Org/10.19347/j.Cnki.2096-1413.202221022.

Event Description

Title: comparison of the effects of traditional operation and selective hemorrhoidectomy and anastomosis in the treatment of severe hemorrhoids.The objective of this study is to compare the effects of traditional operation and selective hemorrhoidectomy and anastomosis in the treatment of sever hemorrhoids.Between january 2019 to december 2020, a total of 120 patients with severe hemorrhoids who were admitted to the hospital were selected and divided into 60 control and observation groups.The control group had 34 men and 26 women and the mean age was 23 to 71 years.In the observation group, 36 men and 24 women were observed and the mean age was 24 to 72 years.The observation group had shorter anal pruritus, swelling, hemorrhage, and pain relief than the control group.The anoscope was placed and gently rotated to adjust the angle of the anoscope and fix the anoscope after fully exposing the hemorrhoids and hemorrhoidal mucosa.Johnson & johnson absorbable suture was used to perform segmented traction suture at about 30 mm from the dentate line of anus in patients, and the depth needed to reach the submucosa.Reported complications included anal pruritus (n=?), swelling (n=?), hemorrhage (n=?), pain (n=?).In conclusion, the use of selective hemorrhoids with mucosectomy as compared with traditional surgery has been effective in severe hemorrhoids treatment, helping to improve the clinical symptoms and prognosis of patients.And it's safe, it's worth promoting.

• 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: 17943464
• MDR Text Key: 325794524
• Report Number: 2210968-2023-07823
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: 09/28/2023
• 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