MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 3INX4IN; BARRIER, ABSORBABLE, ADHESION

Catalog Number	4350
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2025 and absorbable adhesion barrier was used.It was found that there was a something like dust inside the sterilized package when tried to use the absorbable adhesion barrier during the operation.This event was found before use.Another product was used to complete the case.No sample will be returned.There were no adverse consequences to the patient.Further details are not provided from the hp.
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.The following information was requested, but unavailable: are there photos of the "dust" available for visual analysis? no have.Were there any issues with the seal of the sterile packaging? unknown.Are there any tears/holes in the sterile packaging? unknown.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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Brand Name: GYNECARE INTERCEED 3INX4IN
• 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 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22341411
• Report Number: 2210968-2025-07517
• Device Sequence Number: 15743362
• Product Code: MCN
• UDI-Device Identifier: 10705031005396
• UDI-Public: (01)10705031005396(17)280229(10)TKE3781
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4350
• Device Lot Number: TKE3781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2023
• 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
• Patient Sex: Unknown