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

Catalog Number	4350XL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Obstruction/Occlusion (2422)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a laparoscopic sigmoidectomy on an unknown date and an absorbable adhesion barrier was used.An intestinal obstruction occurred after surgery when the absorbable adhesion barrier was applied just below the umbilical wound.Reoperation was performed, the absorbable adhesion barrier was stuck to the small intestine and caused redness and inflammation.The small intestine in that area had become folded and caused an intestinal obstruction.The inflamed small intestine was removed and reconstructed.It was confirmed that the patient has been discharged from the hospital at this time.The doctor in charge has asked whether there have been any reports of similar health problems.No sample will be returned.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) 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 inc, 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 response was provided: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 70-year-old male.Weight and bmi are unknown.Date of index surgical procedure? unknown.The diagnosis and indication for the index surgical procedure? laparoscopic sigmoid colectomy was performed.The subject product was applied beneath the small umbilical incision to prevent postoperative adhesions.Were any concomitant procedures performed? following the onset of bowel obstruction, a reoperation was performed.During the reoperation, adhesion and inflammation between the subject product and the small intestine were observed.It was confirmed that the affected portion of the small intestine had folded, resulting in bowel obstruction.The inflamed segment of the small intestine was subsequently resected and reconstructed.Other relevant patient history/concomitant medications? not available.How was the product applied? one layer? wadded? unknown.Was meticulous hemostasis performed prior to use of product? unknown.What color was the interceed prior to closure? unknown.Did the interceed come in contact with heme prior to use? unknown.What symptoms did the patient experience following the index surgical procedure? onset date? bowel obstruction occurred, but the onset date is unknown.When was the obstruction first noted by a physician? unknown.What is the physician¿s opinion as to the etiology of or contributing factors to this event?not available.What is the patient's current status? as of (b)(6) 2025, it has been confirmed that the patient has been discharged from the hospital.Product lot number? unknown.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23084812
• Report Number: 2210968-2025-10677
• Device Sequence Number: 18603867
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P880047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male