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

Catalog Number 4350XL

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

Patient Problems Inflammation (1932); Pain (1994)

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 additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.The patient demographic info: age, gender, weight, bmi at the time of index procedure product lot number.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that the patient underwent a laparoscopic hepatectomy on (b)(6) 2018 and for the hepatoduodenal mesenterium, the absorbable adhesive barrier was placed between the bottom of the liver and the duodenum of the stomach.The absorbable adhesive barrier was contacted on the gallbladder.The absorbable adhesive barrier was used for lowering the adhesion risk when doing the pringle method in case of a reoperation.Two or three days after the surgery, the patient complained of pain on the right flank in the ward.The pain was like murphy¿s sign.And the patient¿s crp level and liver enzyme level rose.It was reported that cholecystitis occurred.Image diagnosis was not performed.The symptom was relieved by 3 days fasting and antibiotic administration.As of (b)(6), the patient has been discharged from the hospital.The surgeon commented that there was no causal relationship between the device and the event.

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: the patient demographic info: age, gender, weight, bmi at the time of index procedure =>no further information is available.Product lot number =>possible lot was mgb6681.What is physician¿s opinion as to the etiology of or contributing factors to this event? =>no further information is available.What is the patient's current status? =>the patient has been discharged.

• 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: 8247835
• MDR Text Key: 133057138
• Report Number: 2210968-2019-78402
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• 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: 12/18/2018

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: 04/30/2023
• Device Catalogue Number: 4350XL
• Device Lot Number: MGB6681
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/30/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention