MAUDE Adverse Event Report: ETHICON INC. INTERCEED (TC7) UNKNOWN PRODUCT; BARRIER, ABSORBABLE, ADHESION

Catalog Number INTERCEEDUNK

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

Patient Problems Adhesion(s) (1695); Diarrhea (1811); Pain (1994); Not Applicable (3189)

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: i feel i should get through this surgery and obtain more knowledge before i proceed with submitting a signed release and my op report from (b)(6) 2015.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.This medwatch report is in response to receipt of maude event report mw5082100.

Event Description

It was reported that the patient underwent an unknown abdominal procedure for extensive abdominal adhesion formation on (b)(6) 2015 and the absorbable adhesive barrier was used.Immediately after the procedure, the patient experienced loose bowel habits but within three months developed severe bile acid malabsorption.It was also reported that for the past three years, the patient was not able to go out of her home if she could not have immediate access to a restroom there.The patient experienced loud gurgling and discomfort after eating, then immediately bile diarrhea.The patient experienced also hair loss, frequent abdominal aches about two inches to the right of the umbilicus, loss of appetite due to fear of eating.The doctor opined that he has not heard of others with these issues.The patient was treated for ibs with no improvement.After nearly two years, the patient saw endocrinologist and was prescribed with colestipol which helped to control bile by absorbing it but not completely.Ct and pet scans were performed, including the abdomen and pelvic area.The pet scan disclosed a spot in the right lung and the patient must have surgery next week on (b)(6) 2019.The thoracic surgeon opined that scans do not have the appearance they normally see with malignant nodules and masses, though they cannot rule out malignancy until they get pathology.It was also reported that the spot is high in the right lung and is increasing in size but is not in a position that would be safe to perform a ct guided needle biopsy, so the patient will undergo a vats biopsy on (b)(6) 2019 and depending on what the frozen section pathology shows, they may proceed with a lobectomy to remove it.No further information is available.

Manufacturer Narrative

Additional information was requested, and the following was obtained: " the p.E.T.Scan disclosed a spot in my right lung and must have surgery next week (b)(6) 2019.Both the pulmonologist and the thoracic surgeon have expressed that my scans (ct & pet) do not have the appearance they normally see with malignant nodules and masses, though they can't rule out malignancy until they get pathology.The spot is high in my right lung and is increasing in size but is not in a position that would be safe to perform a ct guided needle biopsy, so i will undergo a vats biopsy on (b)(6) 2019 and depending on what the frozen section pathology shows, they may proceed with a lobectomy to remove it.I feel i should get through this surgery and obtain more knowledge before i proceed with submitting a signed release and my op report from december 2015.¿.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• 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: 8269516
• MDR Text Key: 133831674
• Report Number: 2210968-2019-78553
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

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: INTERCEEDUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/22/2019
• Supplement Dates Manufacturer Received: 01/18/2019
• Supplement Dates FDA Received: 01/24/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention