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

Catalog Number	4350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Shock (2072)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What was the date of index surgical procedure? 3.What were the diagnosis and indication for the index surgical procedure? 4.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.5.Was there any intraoperative concurrent use of other products? 6.Was meticulous hemostasis performed prior to use of product? 7.What color was the interceed prior to closure? (if brown or black then hemostasis was not adequate).8.Did the interceed come in contact with heme prior to use? 9.How was the product applied? one layer? wadded? 10.What suture was used to close the uterine incision? (for instance, silk suture is much more reactive than other sutures to the surrounding tissues).11.Was there excessive tissue desiccation (cautery use) at the site of interceed application? 12.Were other products (ie seprafilm, anti-adhesion products) used? 13.Were there any surgical complications? 14.How was the shock managed? 15.What was the onset date? 16.Were cultures or sensitivities performed? if yes, what were the results? 17.Has any surgical or medical intervention been performed? 18.What is physician¿s opinion as to the cause of this event? 19.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative event? 20.What is the patient¿s current status? 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.
Event or Problem Description
It was reported that a patient underwent a myomectomy procedure on an unknown date and absorbable hemostatic barrier was used.During surgery, after the interceed was placed on the surgical wound, the patient exhibited shock symptoms.The product was subsequently removed, and emergency measures were taken.The patient has been transferred to the icu currently, and it could not be ruled out whether this event is related to the use of the product.Additional information was requested.

• Brand Name: GYNECARE INTERCEED
• Common Device Name: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 25547749
• Report Number: 2210968-2026-06463
• Device Sequence Number: 16135374
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: (01)10705031005396(17)300131(10)109D6U
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2026

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: 4350
• Device Lot Number: 109D6U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Supplement Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2025
• 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