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); Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 04/05/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a c-section procedure on (b)(6) 2023 and an absorbable adhesion barrier was used.The patient was still in pain after 4-5 days.Moreover, the patient complained of pain in the right lower abdomen.Therefore, the abdomen was opened again, the product was removed, and the abdominal cavity was cleaned, and the pain disappeared.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: 1.Was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.The abdomen was opened again, the product was removed, and the abdominal cavity was cleaned, and the pain disappeared.2.What is the procedure name and date? procedure was a c-section and date was (b)(6) 2023.3.What is the most current patient status? the pain disappeared, so there is no problem with the patient.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.Were any concomitant procedures performed? other relevant patient history/concomitant medications? please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Please describe any medical intervention required to treat the patient condition including medication name and results.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.Please provide the date and results of the product removal.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? 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.

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 female.Were any concomitant procedures performed? no.Other relevant patient history/concomitant medications? not reported please describe the patient manifestations of the reported reaction (location, severity, appearance, systemic or local reaction).Pain lower at right abomen please describe any medical intervention required to treat the patient condition including medication name and results.Not medical treatment, but re-open the wound and washing abdominal cavity.Does the patient have a known allergic history to any medical devices, food and/or medication? unk was allergy testing performed? if so, please describe with results.Unk please provide the date and results of the product removal.March 29 and pain was disappeared.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=>the surgeon has been using the product for many years and has a high level of trust in the product and thinks that the patient and the product were incompatible.What is the patient's current status? pain was disappeared.

• 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: 16832262
• MDR Text Key: 314191501
• Report Number: 2210968-2023-03093
• 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: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• 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
• Date Manufacturer Received: 05/19/2023
• 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): Required Intervention
• Patient Sex: Female