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

Model Number 4350XL

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

Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Peritonitis (2252); Obstruction/Occlusion (2422)

Event Date 04/03/2023

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, 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? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? how was the interceed placed? please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? if so, please provide the results.Please describe any medical intervention performed including medication name and results.What is opeporix? was the interceed removed during the emergency laparotomy? 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 total laparoscopic hysterectomy on (b)(6) 2023 and an absorbable adhesion barrier was used.An infection occurred and an emergency laparotomy was performed on (b)(6) 2023 under general anesthesia.The patient was experiencing abdominal pain, fever and peritonitis.There was no perforation or vaginal dehiscence, but there was extensive peritoneal inflammation.The tlh was completed as usual procedure, but the event occurred.Opeporix and arista were used on the vaginal stump.It is unknown what was the cause of the event.The hospitalization was extended.An ileus tube was placed in hospital and the patient's condition is now 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 was requested and the following was obtained: please provide the patient's demographic information including age, weight, bmi at the time of index procedure date and name of index surgical procedure?emergency laparotomy due to infection after total laparoscopic hysterectomy the diagnosis and indication for the index surgical procedure? infection were any concomitant procedures performed?no what symptoms did the patient experience following the index surgical procedure? onset date? infection.Other relevant patient history/concomitant medications?unknown.How was the interceed placed? normally.Please describe the patient manifestations of the reported infection (location, severity, appearance, systemic or local infection).Wide range but there was not a hall.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure?not reported.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no.Were cultures performed? if so, please provide the results.Unk please describe any medical intervention performed including medication name and results.No.Ileus tube was fed.What is opeporix?¿synthetic absorbable suture (poly-glycol) from other company.What is the physician¿s opinion as to the etiology of or contributing factors to this event?the surgeon couldn't identify the cause.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 SARL-NEUCHATEL; puits godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16769451
• MDR Text Key: 313585865
• Report Number: 2210968-2023-02825
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/23/2023
• 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): Hospitalization; Required Intervention
• Patient Sex: Female