MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 5INX6IN; BARRIER, ABSORBABLE, ADHESION

Catalog Number 4350XL

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

Patient Problem Pain (1994)

Event Date 02/22/2024

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.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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? was meticulous hemostasis performed prior to use of product? how was the product applied? one layer? wadded? was there excessive tissue desiccation (cautery use) at the site of interceed application? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? location and character of pain? please describe any medical intervention given for pain management including medication name and results.Please provide the date and surgical findings of the reoperation performed.Interceed location and integrity at time of reoperation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

Event Description

It was reported that a patient underwent a total laparoscopic hysterectomy on (b)(6)2024 and an absorbable adhesion barrier was used.On the first postoperative day, in the ward / icu, the patient complained of abdominal pain and a re-operation was performed.(seprafilm was used in the tlh, but it did not stick well, so the absorbable adhesion barrier was used in combination.) at the time of re-operation, the patient had no symptoms of infection.It was also added that during the surgery on (b)(6), no intraoperative operations that would have caused abdominal pain were performed.At the time of the re-operation, there were no signs of infection, and the speed at which the patient complained of abdominal pain was rapid considering infection, so the surgeon believes that the foreign body sensation from either product may be the cause.Additional information has been requested.After re-operation, the patient's condition is stable.When the patient's condition was checked on the morning of february 26th (monday), the patient¿s symptom was still stable.Additional information has been requested.

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.Additional information: a3b, h6 additional information was requested and the following response was obtained: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure female date and name of index surgical procedure? on (b)(6) 2024 the diagnosis and indication for the index surgical procedure? unk were any concomitant procedures performed? no was meticulous hemostasis performed prior to use of product? unk how was the product applied? one layer? wadded? one layer was there excessive tissue desiccation (cautery use) at the site of interceed application?unk what symptoms did the patient experience following the index surgical procedure? onset date? first day post-op other relevant patient history/concomitant medications?no location and character of pain? abdominal please describe any medical intervention given for pain management including medication name and results.Reoperation please provide the date and surgical findings of the reoperation performed.Removal interceed location and integrity at time of reoperation? unk what is the physician¿s opinion as to the etiology of or contributing factors to this event? this event may be caused foreign matter reaction by interceed or seprafilm (concomitant adhesion barriar of other company) what is the patient's current status? stable product lot number?= unk.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18898672
• MDR Text Key: 337617802
• Report Number: 2210968-2024-03033
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2024
• Initial Date FDA Received: 03/13/2024
• 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