MAUDE Adverse Event Report: ETHICON INC. INTERCEED (TC7) UNKNOWN PRODUCT; BARRIER, ABSORBABLE, ADHESION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/01/2014

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 provided by the patient: 1.What type of surgery did you have? joint laparoscopic cholecystectomy converted to open cholecystectomy, exploratory laparotomy with lysis of adhesions and oophorectomy.2.What was the reason for this surgical procedure? pelvic pain, adhesions from previous surgeries, and ovarian cyst.3.Please provide the date of surgery.(b)(6) 2014.4.When did the issues begin? weeks after surgery.5.If in your possession, may we have a copy of your operative report(s)? yes.6.Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? yes.Included is the signed authorization for ethicon to contact my surgeon.Attempts are being made to obtain the following information from the surgeon.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 and bmi at the time of index procedure.Other relevant patient history/concomitant medications? please describe any medical intervention given for the reported pain or inflammation including medication name and results.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 code and lot number of the interceed? 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 joint laparoscopic cholecystectomy converted to open cholecystectomy, exploratory laparotomy with lysis of adhesions and oophorectomy on (b)(6) 2014 and an absorbable adhesion barrier was used.The patient reported that the procedure was to scrape and remove adhesions and to remove an adhered ovary and gallbladder.It was found that the adhesions were too severe for laparoscopic.The patient reported that they now have chronic inflammation, pain, etc.And is not sure whether the product may be an issue.They have been suffering from chronic inflammation for the past 9 years.Additional information has been requested.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18493908
• MDR Text Key: 332674914
• Report Number: 2210968-2024-00315
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/11/2024
• 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): Other
• Patient Age: 36 YR
• Patient Sex: Female