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

Model Number 4350XL

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

Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure date of initial surgical procedure what are the patient comorbidities/concomitant medications?   date, time of onset of infection and inflammation from the 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? were cultures performed? results? product lot # does the surgeon believe there was any deficiency with the interceed involved? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? the site of application is just below the small incision and is the same as the site of fluid retention.Antibiotics alone were administered.After the administration of antibiotics, the patient's condition improved.Progress: inflammation level was high until pod 5, but rapidly improved after administration of antibiotics.(there is a comment that the patient's condition may have improved even without administration of antibiotics.).Health injury details: abdominal pain.Seriousness: not serious.Reason of the seriousness: inflammation level was high until pod 5, but rapidly improved after administration of antibiotics.(there is a comment that the patient's condition may have improved even without administration of antibiotics.) the surgeon commented that if the interceed was the cause of infection, the symptoms might not improve so quickly.At the time of inflammatory reaction, crp was recorded at 2 digits and white blood cells at 10,000 or higher.Other contributing factor - although the interceed was not handled with dirty forceps that grasped the intestinal tract, etc., the surgeon said that he might have been a little careless because he had gotten used to the surgery after being transferred.

Event Description

It was reported that a patient underwent a laparoscopic colectomy on an unknown date and the absorbable adhesion barrier was used.It was reported that the patient experienced a postoperative inflammatory reaction value that was high.Based on the ct analysis results, there was a possibility of infection signs.There was fluid accumulated just under the incisional wound.Administration of antibiotics was started.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4) date sent to the fda: 10/01/2021 this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure =>no further information is available.Date of initial surgical procedure =>no further information is available.What are the patient comorbidities/concomitant medications? =>antibacterial drug.Date - time of onset of infection and inflammation from the surgical procedure? =>no further information is available.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? =>antibiotics were administered.Were cultures performed? results? =>no further information is available.Product lot # =>no further information is available.Does the surgeon believe there was any deficiency with the interceed involved? =>no further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? =>there is no other possible cause of inflammatory reaction such as suture failure.Because fluid was accumulated just under the incisional wound, it may be an infection caused by interceed.What is the patient's current status? =>after the administration of antibiotics, the patient's condition improved.No further information will be provided.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12375091
• MDR Text Key: 268445465
• Report Number: 2210968-2021-07743
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention