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 Problems Abdominal Pain (1685); Septic Shock (2068); Urinary Retention (2119); Peritonitis (2252); Fluid Discharge (2686)

Event Date 12/11/2023

Event Type  Death  

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 weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? were there any intra-operative complications? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? does the surgeon believe the interceed caused or contributed to the reported leak/death? was a cause of death reported within the medical record or described in an autopsy report? if so, please specify.Would the surgeon like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? 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 laparoscopic-assisted sigmoidectomy procedure on (b)(6) 2023 and an absorbable adhesion barrier was inserted through a trocar and applied directly below the abdominal wall incision.The surgery ended at 16:30 on monday, (b)(6).At 20:43 on monday, (b)(6), the patient's blood pressure decreased (79/46).The surgeon thought the antibiotics were too effective and lowered the dose of meropenem.Two hours passed, but the patient's blood pressure did not return to normal, so the meropenem prescription was discontinued.The patient couldn't urinate.On the morning of tuesday, (b)(6), the patient's blood pressure had not returned to normal and he still did not urinate.The crp level increased, there was an inflammatory response, and the white blood cell count decreased to 830.There was no problem with his level of consciousness.On the morning of wednesday, (b)(6), the patient complained of abdominal pain.At 3:30 on thursday, (b)(6), the patient died.According to the nurse's records, waste fluid was being produced until the patient died.(at 19:54 on tuesday, (b)(6), another doctor checked the waste fluid.The record stated that it was ¿dark brown'' and that ¿the color of the waste liquid seems to have changed due to the use of the absorbable adhesion barrier.'' at 7:00 on wednesday, (b)(6), the same doctor's record was also "brown.").The surgeon commented that the septic shock was due to leakage and also death from peritonitis, but the absorbable adhesion barrier never affected the leakage.Additional information has been requested.

• 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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18484053
• MDR Text Key: 332556420
• Report Number: 2210968-2024-00275
• 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 Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/08/2024
• 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): Death
• Patient Age: 85 YR
• Patient Sex: Male