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 Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Not Applicable (3189)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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: were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no further information is available.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no further information is available.What was a cause of infection on 3rd day after initial surgery? it was presumed that, by being exposed to outside, infection and highly contaminated abscesses occurred.Was there any deficiency or anomaly of the interceed? if yes, please describe it.No further information is available.Was there any issue with interceed packaging? if yes, please describe it.No further information is available.Were cultures performed? results? no further information is available.Please provide details of wound injury? when was it occurred? no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this infection and abscess? it was presumed that, by being exposed to outside, infection and highly contaminated abscesses occurred.What is the current patient status? the patient is hospitalized.Sorry for late reply.No further information will be provided.

Event Description

It was reported that the patient underwent an ileus release operation/clean-contaminated operation for adhesive bowel obstruction on (b)(6) 2019 and just before abdominal closure, the absorbable adhesive barrier was placed on the pelvic floor, between the pelvic floor and the partially resected small intestine, where adhesions are expected and under the lower abdomen midline wound in front of the greater omentum.The bowel obstruction improved after the operation, but ct scan was performed on the 5th day because inflammation was prolonged.Also, wound infection occurred on the 3rd day, and heavy exudate was confirmed from the wound site.It was confirmed fist-sized abscesses on the pelvic floor and under the wound site by ct scan.By the result of the ct scan, emergency reoperation was performed on (b)(6) 2019.From the view of the reoperation, direct cause of the abscesses related to bowel obstruction surgery such as suture failure was not confirmed.The abscess under the abdominal wall is localized on the dorsal side of the wound on the ventral side of the omentum, and the abscess is a cream-colored pus with a bad odor, and the dorsal side of the abscess wall was made up of the gelled absorbable adhesive barrier.Fluid pooled between the device which was stuck to the abdominal wall, the back of the wound, and the peritoneum, and it leaked into the crevice between the wound.It was presumed that, by being exposed to outside, infection and highly contaminated abscesses occurred.The abscess on the pelvic floor was covered with the gelled absorbable adhesive barrier, and it was cloudy dark red colored liquid.The small intestine which had fallen into the pelvis due to the gelled absorbable adhesive barrier had been pushed out to the head side.This tumor is also presumed to be fluid abscess formed between the absorbable adhesive barrier stuck to the pelvic floor and the peritoneum.Both abscesses were cleaned, and drained, and gelled device was removed as much as possible.Originally, it was a semi-clean operation, but the wound was contaminated by re-operation, and it is now forced to manage as a highly contaminated wound.Although there was pus just below the wound, the contents of the pelvic floor were dark red liquid by absorbable adhesive barrier.The patient is still hospitalized with wound injury as it is open wound.The doctor opined that it was presumed that, by being exposed to outside, infection and highly contaminated abscesses occurred.No further information is available.

• 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 00754
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8891312
• MDR Text Key: 154267132
• Report Number: 2210968-2019-85517
• 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
• Report Date: 07/17/2019

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: 07/17/2019
• Initial Date FDA Received: 08/13/2019
• 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: 41 YR