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

Catalog Number 4350XL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fever (1858); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Not Applicable (3189)

Event Date 11/11/2017

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.Additional information was requested and the following was obtained: - on (b)(6), the open distal gastrectomy was performed from 9:00 to 14:00.Reconstruction was done by roux-en-y method.No drain was placed.Just before closing the surgical wound on the abdominal wall, the interceed was placed which was divided to 2 pieces.One of them was applied on the surface of the liver, and the other was applied just above the small bowel.- on november 11, the patient had a fever of 40 degrees celsius.- on november 12, the fever went down to 39 degrees celsius.It was confirmed by ct images that ascites fluid had been accumulated just under the abdominal wall.There was no sign of infection on the surgical wound.When re-incising the distal end of the surgical wound, a small amount of ascites fluid was drained.After that, the patient got better.- on (b)(6) the patient started eating.- on (b)(6) the fever went down to 37 degrees celsius.- on (b)(6) the patient was discharged from the hospital.The hospitalization was not delayed.Additional treatments due to this event were not performed.[surgeon¿s opinion about causal relationship between interceed and event] the fever and abdominal pain were foreign body reaction due to the interceed.[seriousness] not serious (moderate/ minor) [reason of seriousness] there was no sign of infection.No additional treatments were performed.The surgeon commented the symptom as peritoneal inflammation associated with foreign body reaction.

Event Description

It was reported that the patient underwent an open distal gastrectomy reconstruction procedure on (b)(6) 2017 by roux-en-y method and the absorbable adhesive barrier was divided to two pieces and applied on the surface of the liver and just above the small bowel under the abdominal wall before closing the surgical wound on the abdominal wall.After the procedure, on (b)(6) 2017, the patient experienced fever, 40 degrees celsius, and abdominal pain.The crp value was high.On (b)(6) 2017, the fever went down to 39 degrees celsius.Ct image confirmed inflammation and ascites fluid accumulated just under the abdominal wall, around the area to which the absorbable adhesive barrier had been applied.As of (b)(6) 2017, fever was going down and the abdominal pain was subsiding; however, the crp value is still high.There was no sign of infection on the surgical wound.Gastrointestinal endoscopy was planned on (b)(6) 2017.When re-incising the distal end of the surgical wound, a small amount of ascites fluid was drained.After that, the patient got better.On (b)(6) 2017, the patient started eating.Next day the fever went down to 37 degrees celsius.The patient was discharged from the hospital on (b)(6) 2017.The hospitalization was not delayed.The surgeon opined that the fever and abdominal pain were foreign body reaction due to absorbable adhesive barrier.The surgeon also opined that the peritoneal inflammation associated with foreign body reaction.

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7100822
• MDR Text Key: 94276617
• Report Number: 2210968-2017-71687
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

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 Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/29/2017
• Initial Date FDA Received: 12/08/2017
• 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 Age: 75 YR