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); Inflammation (1932); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, date of initial surgical procedure? the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? product lot #? were any concomitant procedures performed? onset date/time of the pain from surgery? character of the pain? is there any specific activity that precipitated the pain or eased the pain? what medical intervention was given for the pain management? results? if reoperation was performed please provide date and surgical findings was the device removed? if so, please date and details of the re-operation.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?  .

Event Description

It was reported that a patient underwent a pancreaticojejunostomy on an unknown date and the adhesion barrier was implanted.The site of use is just below the abdominal wall.It was reported that the 2nd postoperative day after the surgery, the patient had brown drainage, abdominal pain, and crp level tended to increase.A ct showed a shadow of the device.Ascites had not developed.The opined that pancreatic fluid leakage was suspected, and its effect may be possible.Both ascites and pancreatic leak were suspected.Drainage and follow-up were performed as treatments for ascites and pancreatic leak.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/15/2021.  additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure =>it is difficult to get the information.Date of initial surgical procedure =>it is difficult to get the information.The diagnosis and indication for the initial surgical procedure? =>pancreaticojejunostomy.What were current symptoms following the index surgical procedure? onset date? =>the symptom occurred on the 2nd postoperative day after a pancreaticojejunostomy.What are the patient comorbidities/concomitant medications? =>it is difficult to get the information.Product lot # =>it is difficult to get the information.Were any concomitant procedures performed? =>it is difficult to get the information.Onset date/time of the pain from surgery =>on the 2nd postoperative day after a pancreaticojejunostomy.Character of the pain? =>abdominal pain.Is there any specific activity that precipitated the pain or eased the pain? =>it is difficult to get the information.What medical intervention was given for the pain management? results? =>drainage and follow-up are performed as treatments for ascites and pancreatic leak.If reoperation was performed please provide date and surgical findings =>reoperation was not performed.Was the device removed? if so, please date and details of the re-operation.=>n/a what is the physician¿s opinion as to the etiology of or contributing factors to this event? =>pancreatic fluid leakage was suspected, and its effect may be possible.What is the patient's current status? =>it is difficult to get the information.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, 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.

• 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: 11826636
• MDR Text Key: 263409967
• Report Number: 2210968-2021-04655
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

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 Model Number: 4350XL
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/16/2021
• Supplement Dates FDA Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention