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 Problems Blood Loss (2597); Not Applicable (3189)

Event Date 01/04/2019

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.

Event Description

It was reported that the patient underwent a laparoscopic assisted radical resection for colorectal cancer procedure on (b)(6) 2019 and the adhesive absorbable barrier was used.It was also reported that two days after surgery, the anastomotic bleeding occurred and the patient underwent the second surgical procedure on (b)(6) 2019, for exploration and hemostasis.The anastomotic bleeding was found during the surgery and was sutured to stop bleeding along with compression and tamponade.As reported, it was not related to the study device.The doctor opined that the occurrence of anastomotic bleeding is probably related to the surgery and this patient takes aspirin daily, might have an impact.The outcome resolved and healed without sequela.

Manufacturer Narrative

It was reported that the event is not related to the device.This device is not serious injury reportable.Therefore, this medwatch report is not reportable.

• 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: 8359143
• MDR Text Key: 136786543
• Report Number: 2210968-2019-78991
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• 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
• Date Manufacturer Received: 02/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR