MAUDE Adverse Event Report: ETHICON INC. INTERCEED (TC7)7.6 CM X 10.2 CM; BARRIER, ABSORBABLE, ADHESION

Catalog Number M4350

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.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 clarify what does ¿possible unrelated¿ mean? was this intestinal obstruction related to the interceed or not related? please specify.Are you indicating that the device is a potential cause of the reported intestinal obstruction? what does the doctor believe is the etiology of the intestinal obstruction outcome?.

Event Description

It was reported that the patient underwent a laparoscopic rectal carcinoma radical resection/dixon and preventive ileostomy procedure on (b)(6) 2019 and the absorbable adhesive barrier was used.The device was still retained in the patient when the intestinal obstruction occurred three days after the surgery, on (b)(6) 2019.It was reported that the patient required hospitalization or prolongation of existing hospitalization.In summary, it was reported the intestinal obstruction was definitely related to the surgery, and possible unrelated to the absorbable adhesive barrier.After the intestinal obstruction, the symptomatic treatment was conducted including gastrointestinal nutrition support.Then the patient healed and discharged about 1 week later.It was confirmed the event healed without sequela.It was also reported that the end date of outcome was (b)(6) 2019.Additional information has been requested.

Manufacturer Narrative

Method codes: 3331.The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.Additional information was requested, and the following was obtained: please clarify what does ¿possible unrelated¿ mean?: unlikely.Was this intestinal obstruction related to the interceed or not related? please specify.: investigators judged unlikely.Are you indicating that the device is a potential cause of the reported intestinal obstruction?: investigators judged unlikely, it means the event is unlikely associated.What does the doctor believe is the etiology of the intestinal obstruction outcome?: it is mechanical incomplete intestinal obstruction.Relationship with phase 1 surgery: definitely related.

• Brand Name: INTERCEED (TC7)7.6 CM X 10.2 CM
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8755023
• MDR Text Key: 149845353
• Report Number: 2210968-2019-83603
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

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 Expiration Date: 04/30/2022
• Device Catalogue Number: M4350
• Device Lot Number: 3930918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 07/18/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR