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 Fever (1858); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)

Event Date 08/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a single-incision laparoscopic appendectomy on (b)(6) 2018 and an absorbable adhesion barrier was used.On (b)(6) 2018, the patient visited the hospital and complained of fever of 38 degrees.The patient was administered antibiotic medication for 4 days due to high level of crp and pain.The patient¿s condition was not improved.It was confirmed that there had been an abscess formation at the site of the upper side where the barrier was placed which was under the abdominal wall.On (b)(6) 2018, a reoperation was performed for removal of infectious site.In reoperation, since the product was in the state of being dissolved in the omentum, all of the product could not be excised.Abscess drainage was performed and adhesion prevention material was not used.In bacteria culture, enterococcus and bacteroides were detected in addition to klebsiella.The incision site was closed after the infectious site was removed and wash was performed.The surgeon opined that causal relationship between the barrier and the event is unsure.The patient has few inflammation reaction and was under scheduled appendectomy, so the risk was low though high bmi.It was reported that it was found that there had been a mass of germ in deep area of the body.There is a possibility that the mass of the germ dropped under the abdominal wall.The patient is hospitalized currently, but recovering smoothly postoperatively.No additional treatment is planned.

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7885885
• MDR Text Key: 120572929
• Report Number: 2210968-2018-75878
• 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: 08/20/2018

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 Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 90