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

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

Patient Problems Pain (1994); Urinary Retention (2119); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Title: observation on the efficacy of shaobai injection combined with surgery in the treatment of moderate and severe hemorrhoids.This study aims to observe the therapeutic effect of shaobai injection combined with surgery on moderate and severe hemorrhoids.From january 2018 to september 2019, 108 patients with moderate to severe hemorrhoids were admitted due to pain and bleeding after surgery.All consistent with hemorrhoids.The patients were divided into study group (n = 50) and control group (n = 50) according to different treatment methods.The study group consisted of 28 males and 30 females, aged 27-69 (48.52 ± 2.45) years.In the control group, there were 24 males and 26 females, aged 26-72 (48.54 ± 2.48) years.Study group underwent selective hemorrhoidopexy (ri 'st) + shaobai injection: (1) instrument: johnson & johnson ec60a tst disposable anastomosis device, anal dilator, etc.During surgery in this group, a johnson & johnson 2.0 absorbable suture with round needle is used for segmental purse-string suture of mucosa and submucosa on diseased hemorrhoids.In the control group, except that peony injection was not used, the other preoperative and intraoperative methods were consistent with those in the study group.The patients were followed up for 6 months, and long-term complications (anal stenosis, recurrence, etc.) were recorded.Reported complications included: (n=?) the melting cure rate was 81.03% higher than 52.Oo% in the control group.(n=?) pain.Short-term complications : (n=?) anal swelling and (n=?) urinary retention.Long-term complications: postoperative recurrence rate was 6.00% (3,50) in the control group.It was concluded , that the clinical effect of shaobai injection combined with surgery in the treatment of moderate to severe hemorrhoids was significant, with few short- and long-term complications, and postoperative anal recovery fusui condition is good and has good clinical application value.

Manufacturer Narrative

Pc-(b)(4).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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: moddia print.Rreat modern diagnostics & therapeutics 2020 mar31 clc: r657.18 document identifier: b article number: loll-8174 (2020) 05-070302.

• 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: 15572326
• MDR Text Key: 301501141
• Report Number: 2210968-2022-08294
• 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

• 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: 09/27/2022
• Initial Date FDA Received: 10/10/2022
• 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