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 Anaphylactic Shock (1703); Rash (2033)

Event Date 04/09/2019

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure other relevant patient history/concomitant medications? please clarify what does it mean that the patient is not allergic? was allergy testing done? if yes, results? was anything given to the patient prior or during the surgery that could cause anaphylaxis? what intervention was done for anaphylactic shock? was the interceed removed? what is the patient¿s status currently? was the event resolved?.

Event Description

It was reported that the patient underwent a hepatectomy procedure on (b)(6) 2019 and the absorbable adhesion barrier was placed on the surface of the liver before closing the surgical wound.During closing the surgical wound, rash was seen on the patient¿s skin, but the wound was closed as it was.After the surgery, anaphylactic shock occurred.The current patient¿s status is stable.The patient is hospitalized currently.It was also reported that causal relationship between the event and the absorbable adhesion barrier is unknown.Additional information has been requested.

Manufacturer Narrative

The patient demographic info: age, weight, bmi at the time of index procedure.No further information is available.Other relevant patient history/concomitant medications? no further information is avaialble.Please clarify what does it mean that the patient is not allergic? the patient do not have allergic diathesis.Was allergy testing done? if yes, results? no further information is avaialble.Was anything given to the patient prior or during the surgery that could cause anaphylaxis? no further information is avaialble.What intervention was done for anaphylactic shock? antihistamines and steroids were administered.Was the interceed removed? no.Remain in the patient's body.What is the patient¿s status currently? as of (b)(6) 2019, the patient's condition is stable and there are no plans to extend the hospital stay.Was the event resolved? yes, current status of the patient is stable.No further information will be provided.

• 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: 8589366
• MDR Text Key: 144395996
• Report Number: 2210968-2019-81151
• 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: 04/10/2019

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: 04/10/2019
• Initial Date FDA Received: 05/07/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention