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 Erythema (1840); Unspecified Infection (1930); Itching Sensation (1943); Not Applicable (3189)

Event Date 04/06/2019

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.Additional information was requested, and the following was obtained: lot number is unknown, please confirm, only provide if the exact lot is available? unknown.Date of the procedure? unknown.Onset of ""infection""? type of infection? unknown.The diagnosis and indication for the index surgical procedure? unknown.It was reported that the infection may be due to not using a wound retractor.Please elaborate for example did not using the retractor result in unexpected injury to underlying tissue due to visibility? unknown.Does the surgeon believe that the infection was as result of the interceed if not please indicated the etiology of the infection for example anastomotic leak or comorbid conditions? unknown.Did the patient receive any medical or surgical intervention as a result of the reported infection? unknown.If yes to question 6, please elaborate on the intervention implemented? how is the patient doing at this time? the patient has been recovered after that.Patient demographics: age, gender, weight, bmi at the time of index procedure, relevant history? unknown.

Event Description

It was reported that the patient underwent a laparoscopic distal gastrectomy on unknown date and the absorbable adhesion barrier was placed between the peritoneum and organs just below the umbilical region of the abdominal wall.The patient experienced infection and the surgeon opined that it may be due to not using a wound retractor.It was confirmed by ct scan that the shape of infection site was the same as the shape of absorbable adhesion barrier.The patient has been recovered after that.No further information is provided.

Manufacturer Narrative

Additional patient codes: 1840,1943, 3189- surgical intervention.Additional information was requested, and the following was obtained: the surgery was performed on (b)(6) 2019.The patient¿s condition was stable for 1 week after the surgery, but redness and pruritus were observed around the umbilical skin on april 6, and there was slight fever.When ct examination was done on april 8, the image showed something white at the site where the interceed was applied.It is unknown if it is an abscess.Deep ssi (fascia) has occurred and enterococci have been cultured.The hospitalization period was extended by two weeks.As a treatment for infection, the umbilical part was sectioned and a subcutaneous drain was inserted.The patient became stable 3 weeks after the infection, was discharged from the hospital and was followed up on an outpatient basis.Current status stable.Surgeon's comment: it might be the cause of the infection that the stomach was removed without the wound retractor.I don't think that interceed is the sure cause.The patient had previously had surgery and was also given steroids.I think that the patient background is also a factor.Patient demographics: age, gender, weight, bmi at the time of index procedure, relevant history? date of the procedure and indication for the index surgical procedure? please elaborate for example did not using the retractor result in unexpected injury to underlying tissue due to visibility? onset of "infection"? type of infection? does the surgeon believe that the infection was as result of the interceed? what was a surgical/medical intervention implemented as a result of the reported infection? was the interceed removed? how is the patient doing at this time? were cultures performed? results? if it is possible, please provide a lot number.

• 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: 8601155
• MDR Text Key: 144746951
• Report Number: 2210968-2019-81284
• 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: 04/17/2019

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 Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/10/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/31/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention