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 Problem Abscess (1690)

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.Additional information was requested and the following was obtained: 1.Please provide lot number.Unknown.2.Was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.2 times of drainage.3.What is the most current patient status? regarding to abscess, there is no problem.The patient has been in a poor general condition originally, and he/she is still repeatedly discharged and hospitalized.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 of 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? please provide the onset date/time of abscess from the initial surgical procedure.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.How much and what type of drainage is present in this wound? was the interceed removed? if so, please provide the date and findings.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? lot number? if the device or further details are received at a later date a supplemental medwatch will be sent.Component code: g07002 ¿ device not returned.

Event Description

It was reported that a patient underwent a laparoscopic gastrectomy on an unknown date and an absorbable adhesion barrier was used just under the wound.Because of the small incision, it was not possible to spread the product properly and apply the product.After that, abscess was confirmed under the umbilicus, the site of application.Subsequently, chemotherapy planned to be performed at the lower part could not be performed because the start of treatment for the abscess was delayed.Drainage was performed twice.Fungi were detected in the abscess.Regarding to abscess, there is no problem, but the patient's general condition is poor, and even after the event, total pelvic exenteration was performed.Even now, the patient is repeatedly hospitalized after being discharged.The surgeon opined that there is a relationship between product and event since the abscess was at the site of product placement.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, gender, weight, bmi at the time of index procedure, unknown.Date of index surgical procedure? unknown.Were any concomitant procedures performed? laparoscope-assisted distal gastrectomy.What symptoms did the patient experience following the index surgical procedure? onset date? abscess was confirmed under the umbilicus, the site of application.Other relevant patient history/concomitant medications? sick on stomach and large intestine.Bad condition all over body.Please provide the onset date/time of abscess from the initial surgical procedure.Unknown.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? sick on stomach and large intestine.Bad condition all over body.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?unknown.Were cultures performed? if so, please provide the results.Yes, fungus was detected.How much and what type of drainage is present in this wound? unknown.Was the interceed removed? if so, please provide the date and findings.Unknown what is the physician¿s opinion as to the etiology of or contributing factors to this event? ¿there was an abscess at the site where the interceed was placed.But the patient's general condition is poor, so i don't think the intereed is the only cause."" what is the patient's current status? no problem with abcess lot number? no further information is available.

• 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; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16372141
• MDR Text Key: 309490691
• Report Number: 2210968-2023-01056
• 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,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: 02/02/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/23/2023
• 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): Required Intervention