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

Catalog Number 4350XL

Device Problems Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Not Applicable (3189)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 diagnosis and indication for the initial surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? what medical intervention was performed for infection? results? were pre-existing adhesion noted during the procedure? the relationship of adhesion to device? why does the surgeon believe that interceed caused infection? the patient demographic info: age, weight, bmi at the time of index procedure.Product lot #.What is the patient's current status? additional information was received: the reoperation was performed using a wound retractor, surgical knives and electric surgical knives.The surgical wound was about 10cm.It was found that the interceed was near the anastomotic part and the it was adhered to the ileum and the greater omentum.The adhesion site was removed and the ileum was sutured by layer to layer suturing.The abdominal cavity was washed with 3000 cc of physiological saline.Then, the drains were placed at the anastomotic part and the douglas' pouch.After that, the seprafilm quarter pack was placed under the abdominal wall and the wound was closed.The wound was sutured with the pds on the fascia and the penrose drain was placed under the skin and the skin was sutured with the nylon by mattress suturing.The drain has not been removed as of the (b)(6).

Event Description

It was reported that the patient underwent a primary procedure of stoma closure on (b)(6) 20018 and the absorbable adhesive barrier was used on the colostomy closure.On (b)(6) 2018, the patient experienced stomachache and it was confirmed the patient has no fever but has difficulty in walking.On (b)(6) 2018, the patient was experiencing a stomachache again and examination was performed.It was found that the level of crp was 20 and white blood cell count was 18000.It was also found the abscess under the abdominal wall where anastomosed.It was also reported that the reoperation was performed on (b)(6) afternoon since there was a possibility that leakage occurred.It was confirmed that there had been no leakage occurred and absorbable adhesion barrier became sclerotic and greyish white.The absorbable adhesion barrier which had been adhered to the ileum and the greater omentum had become the abscess and it caused infection.It was odorless and away from the anastomosis site.The reoperation was performed using a wound retractor, surgical knives and electric surgical knives.The surgical wound was about 10cm.The ileum and the absorbable adhesion barrier was removed since the adhesion between the ileum and the device was not resolvable.The surgeon opined that bacteria were bred on the device as foreign substance.As reported, currently, the patient is in the hospital and the drain has not been removed as of (b)(6) 2018.Additional information has been requested.

Manufacturer Narrative

Pc-000233851 date sent to the fda: 08/09/2018 additional information was requested and the following was obtained on 7/17/2018: the diagnosis and indication for the initial surgical procedure? no information.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no information.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no information.What medical intervention was performed for infection? no information.Results? na were pre-existing adhesion noted during the procedure? it was noticed by ct-scan before the reoperation, because the patient complained of abdominal pain.The relationship of adhesion to device? no information.Why does the surgeon believe that interceed caused infection? the surgeon considers that bacteria were bred on the interceed as foreign substance.The patient demographic info: age, weight, bmi at the time of index procedure product lot # - no information.What is the patient's current status? as of (b)(6), the patient is in the hospital.The following additional information was received: on (b)(6) 2018: the patient was discharged on (b)(6).The pathological examination for the specimen, abscess part and adipose tissue, was done at the hospital, but they couldn¿t find the possible root cause.The doctor commented it may be a coincidence.On (b)(6) 2018: as a result of the pathological examination, bacteria were found.The doctor commented that it was considered to be infection by intestinal bacteria possibility due to leakage.But the leakage wasn¿t found and we don¿t know detail about the leakage.

• 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.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7706704
• MDR Text Key: 114593170
• Report Number: 2210968-2018-74530
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 07/10/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/20/2018
• Supplement Dates Manufacturer Received: 07/17/2018
• Supplement Dates FDA Received: 08/09/2018
• 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
• Treatment: PDS PLUS, STRATAFIX
• Patient Outcome(s): Required Intervention