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 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.This file was reviewed by a cross functional team during the weekly ae review and the following questions were requested and assigned to bq via pcf activity: what initiated this review? is this a part of a study? or was there an increase in cases resulting in a review of charts? please explain.For each of the individual patients, please provide the following: 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? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? please describe any surgical intervention required including the date and results.Does the surgeon believe the reported obstruction was caused or contributed by the interceed used? 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? again, it is important for reporting requirements that the information above is provided for each individual patient.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.(b)(4).Related events captured via: 2210968-2022-09997, 2210968-2022-09998, 2210968-2022-09999, 2210968-2022-10000, 2210968-2022-10002, 2210968-2022-10003, 2210968-2022-10004, 2210968-2022-10005, 2210968-2022-10006, 2210968-2022-10007, 2210968-2022-10008.

Event Description

It was reported that as of (b)(6) 2022, an absorbable adhesion barrier had been used in 196 patients to prevent adhesion.Of these patients, postoperative intestinal obstruction occurred perioperatively in 9 patients (including ruptured suture and paralytic intestinal obstruction) and late (after 6 months postoperatively) in 3 patients.Of the 3 cases of late onset, 2 required surgery: 1 case of strangulated intestinal obstruction due to trabecular substance, and the other case of asbo involving vascular clips and staples of functional end-to-end anastomosis used in the preceding left-sided colectomy.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: what initiated this review? is this a part of a study? or was there an increase in cases resulting in a review of charts? please explain.=>these multiple cases are received from panel discussion os some doctors.The doctor said, "in our department, there have been the cases in which interseed was used to prevent adhesions, of which postoperative intestinal obstruction occurred in 9 cases during the perioperative period and 3 cases during the period more than 6 months after operation.".For each of the individual patients, please provide the following: please describe any surgical intervention required including the date and results.=>of the three cases during the long term, 2 cases required re-operation.Surgeon¿s name? the following information was requested, but unavailable: 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? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? does the surgeon believe the reported obstruction was caused or contributed by the interceed used? 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? related events captured via: 2210968-2022-09997, 2210968-2022-09998, 2210968-2022-09999, 2210968-2022-10000, 2210968-2022-10002, 2210968-2022-10003, 2210968-2022-10004, 2210968-2022-10005, 2210968-2022-10006, 2210968-2022-10007, 2210968-2022-10008, 2210968-2022-10009.

• 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: 15926206
• MDR Text Key: 304953758
• Report Number: 2210968-2022-10009
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 20705031147840
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/19/2023
• 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): Other