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	Abdominal Pain (1685); Abscess (1690); Fever (1858); Solid Tumour (4552)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.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 diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? please describe the patient manifestations of the reported tumor (location, severity, appearance).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? please describe any medical intervention performed including medication name and results.What is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? 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.
Event or Problem Description
It was reported that a patient underwent a laparoscopic-assisted colectomy on (b)(6) 2024 and an absorbable adhesion barrier was used.After double stapling technique anastomosis, the absorbable adhesion barrier was used on the median incision wound directly under the wound.After the surgery, an intra-abdominal tumor formed.Three days after surgery, the patient complained a fever and abdominal pain, so a detailed examination was undertaken.Crp value was 6.7.Antibiotic treatment was started to the stomach, and fever disappeared the next day, but antibiotics were continued.Anastomotic insufficiency was not found.During wound closure at operation, absorbable adhesion barrier was attached just below the umbilical region after confirming there was no intra-abdominal bleeding.After that, the wound was closed.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.Corrected information: h6.Health effect - clinical code.Additional information was requested and the following was obtained: the diagnosis and indication for the index surgical procedure? ¿unk were any concomitant procedures performed?¿no what symptoms did the patient experience following the index surgical procedure? onset date?¿fever, stomach ache and abscess post op 3 days other relevant patient history/concomitant medications?¿no please describe the patient manifestations of the reported tumor (location, severity, appearance).¿abscess intraperitoneal were there any pre-existing signs/symptoms of active infection prior to this surgical procedure?¿no did the patient receive any prophylactic antibiotics pre-, intra- or post-operation?¿yes, post-op please describe any medical intervention performed including medication name and results.¿antibiotics what is the physician¿s opinion as to the etiology of or contributing factors to this event?¿he also want to confirm the relationship, he didn't experience with other anti-adhesion product.What is the patient's current status? =>go good.Product lot number? =>unk.

• 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.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20707234
• Report Number: 2210968-2024-12130
• Device Sequence Number: 8180449
• 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,Followup

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: 11/01/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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