MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 5INX6IN; BARRIER, ABSORBABLE, ADHESION

Catalog Number 4350XL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Fever (1858); Pain (1994)

Event Date 08/26/2019

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: what was indication for the initial surgery? transverse colectomy.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- or intra-operation? no further information is available.Does the surgeon believe that interceed is a cause of this event? no further information is available.What is the patient's most current status? the patient is hospitalized as of (b)(6) 2019.No further information will be provided.

Event Description

It was reported that the patient underwent a laparoscopic transverse colectomy on (b)(6) 2019 and the absorbable adhesive barrier was placed under the abdominal wall.On (b)(6) 2019, the patient had a fever of 38.8 degrees.There was no abdominal pain, but the patient had a slight pain when the affected site was pushed.On (b)(6) 2019, ct scan was performed, and it was found that abdominal abscess had occurred at the part where the absorbable adhesive barrier had been placed.Drainage was performed through a small incision, and 200ml of cloudy white liquid, gray slightly mixed with brown, was collected.It was thin like water, and odorless.Crp level was 13.38.Medication of flumarin was administered for gram-positive bacilli.On (b)(6) 2019, crp level was 11.34.The patient¿s fever became to normal, and she recovered enough to drink water through the mouth.On (b)(6) 2019, crp level was 2.4 and the patient recovered enough to eat food.The patient is hospitalized as of (b)(6) 2019.The patient was treated with anti-cancer drugs, and she has already been recovered enough to eat.The patient is recovering smoothly, and no additional treatment is planned.The patient is recovering after the drainage.The surgeon also opined other contributing factor is that during the surgery, the surgeon handled sigmoid colon and cleaning was performed, but there is a possibility that it was not clean enough.No further information is available.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• 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: 9114411
• MDR Text Key: 166540844
• Report Number: 2210968-2019-88065
• 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: 09/06/2019

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: 09/06/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 09/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR
• Patient Weight: 38