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 Adhesion(s) (1695); Obstruction/Occlusion (2422)

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 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? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? were pre-existing adhesions noted during the procedure? how were the post-procedural adhesions confirmed? what is the severity of the adhesions? was meticulous hemostasis performed prior to use of product? what color was the interceed prior to closure? did the interceed come in contact with heme prior to use? how was the product applied? one layer? wadded? what suture was used to close the uterine incision? was there excessive tissue desiccation (cautery use) at the site of interceed application? please describe any surgical intervention required including the date and results.What is the relationship of adhesions to the device implanted? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product lot number? was there any alleged deficiency with the slr product? 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 rectal surgery on an unknown date and an absorbable adhesion barrier was used at the site of ima root dissection.Postoperatively, the patient developed intestinal obstruction due to adhesion at the ima root site and underwent a re-operation.In the same surgery, an slr was used for small bowel dissection at the time of covering stoma creation, but when seen at the time of stoma closure, the slr ear and small bowel were also adhered.However, those effects were minimal.It is unknown if the absorbable adhesion barrier was the cause of the event or not, but the surgeon believes there is a causal relationship.The patient recovered.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 => unk date of index surgical procedure? unk.The diagnosis and indication for the index surgical procedure? unk.Were any concomitant procedures performed? unk.What symptoms did the patient experience following the index surgical procedure? onset date? postoperatively, the patient developed intestinal obstruction due to adhesion at the ima root site and underwent a re-operation.Other relevant patient history/concomitant medications? unk.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? unk.Were pre-existing adhesions noted during the procedure? no.How were the post-procedural adhesions confirmed? adhesions were suspected due to ileus.What is the severity of the adhesions? unk.Was meticulous hemostasis performed prior to use of product? unk.What color was the interceed prior to closure? unk.Did the interceed come in contact with heme prior to use? unk.How was the product applied? one layer? wadded? one layer.What suture was used to close the uterine incision? unk.Was there excessive tissue desiccation (cautery use) at the site of interceed application? unk.Please describe any surgical intervention required including the date and results.=> the adhesions were resolved by reoperation.What is the relationship of adhesions to the device implanted? what is the physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon answered that the relationship between interceed and adhesions is unclear.What is the patient's current status? the patient recovered.Surgeon¿s name? unk.Product lot number? unk.Was there any alleged deficiency with the slr product? no.

• 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: 17604611
• MDR Text Key: 321757120
• Report Number: 2210968-2023-06107
• 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

• Date FDA Received: 08/23/2023
• 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
• Date Manufacturer Received: 09/15/2023
• 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