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); Pain (1994)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at 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 patient demographic info: age, gender, weight, bmi at the time of index procedure.Date of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? date - time of onset of infection 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? patient symptoms manifestations (location, severity, appearance, systemic or local reaction).Were cultures performed? results? what medical intervention was performed? results? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? please provide a lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event?.

Event Description

It was reported that the patient underwent a right hemicolon surgery on unknown date and the absorbable adhesive barrier was used.After the procedure, the patient experienced infection in the ward.It was reported that infection area was the right under the abdominal wall where the absorbable adhesive barrier was placed on.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: the initial procedure was right hemicolectomy on september 27th.It was possible to eat on october 3rd.The patient said he had pain under the incisional wound after the surgery.As a result of blood test, abnormality was confirmed on october 1st.Abscess was confirmed by ct examination.Oral administration of antibiotics was done.The patient was discharged on october 16.The doctor thought possible cause was interceed.No further information will be provided.Date of initial surgical procedure the diagnosis and indication for the initial surgical procedure? date - time of onset of infection 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? patient symptoms manifestations (location, severity, appearance, systemic or local reaction) were cultures performed? results? what medical intervention was performed? results? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? please provide a lot # what is physician¿s opinion as to the etiology of or contributing factors to this event?.

• 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: 8022442
• MDR Text Key: 125594136
• Report Number: 2210968-2018-76845
• 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,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/05/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/07/2018
• 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: 73 YR