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	Abscess (1690); Adhesion(s) (1695)
Type of Reportable Event	Serious Injury
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.H6 component code: g07002 device not returned.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 the device has not been returned.If the device or further details are received at a 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.Please provide the following patient demographic information if available: age, gender, weight, bmi at the time of index procedure what is the date of the initial surgical procedure? what is the diagnosis and indication for the initial surgical procedure? please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.On what tissue layer was the interceed used? what is the lot #? what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status? patient symptoms manifestations (location, severity, appearance, systemic or local reaction) date - time of onset of abscess/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? were cultures performed? results? what medical intervention was performed? results? was pre-existing adhesion noted during the procedure? what is the relationship of the adhesion to the interceed?.
Event or Problem Description
It was reported that a patient underwent a laparoscopic colectomy on an unknown date and an absorbable adhesion barrier was used under the incision.After that re-operation was performed due to other factors.The area where the adhesion barrier was applied was tangled with fat, forming a mass like an abscess when the laparotomy was performed.There was also adhesion in the same area.It took a long time to remove the adhesion during the re-operation.It was found that the adhesion barrier had adhered to the omentum, and was removed during the reoperation.No sample will be returned.Additional information has been 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 was provided: please provide the following patient demographic information if available: age, gender, weight, bmi at the time of index procedure ? unk what is the date of the initial surgical procedure? unk what is the diagnosis and indication for the initial surgical procedure?unk please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.On what tissue layer was the interceed used? unk what is the lot #? unk what is physician¿s opinion as to the etiology of or contributing factors to this event ?unk what is the patient's current status? unk patient symptoms manifestations (location, severity, appearance, systemic or local reaction) greater omentum date - time of onset of abscess/infection from the surgical procedure?unk were there any pre-existing signs/symptoms of active infection prior to this surgical procedure¿unk did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?¿unk were cultures performed? results? unk what medical intervention was performed? results?unk was pre-existing adhesion noted during the procedure?unk what is the relationship of the adhesion to the interceed?unk the sales rep asked the doctor with above question, but he won't provide detail information because he didn't remember it clearly.

• 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 SARL-NEUCHATEL; puits-godet 20; neuchatel 2000 ; SZ 2000
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 21935230
• Report Number: 2210968-2025-04735
• Device Sequence Number: 20829538
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 07/02/2025
• 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 Sex: Unknown