MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1952
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Additional information was requested, and the following was obtained: ¿ how was the product purchased? on-line sampling ¿ is there an indication of how the product was distributed? on-line ¿ is there any indication of the source? original source is unknown, but online merchant name contains:(b)(6) ¿ based on the packaging, is there any indication of which market the original genuine product may have come from? according to feedback, it looks like counterfeit goods ¿ was any device used on a patient? if so, was there any patient consequence? no investigation summary = > the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned product revealed that it was received, thirty expired samples that pertain to product code 1952.The samples were visually inspected and compared with the graphics within the internal system, product code 1952 with lot number kgb6651.Some discrepancies were identified on the labeling, such as: the timestamps on the seal margin of packages were the same.Besides that, the product artwork writing style and font type did not match the information on file.Based on the samples received, the twenty-three samples are confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.In the remainder no anomalies were found.A manufacturing record evaluation was performed for the finished device batch and no non-conformances were identified.Event related to mw # 2210968-2023-04045, 2210968-2023-04044, 2210968-2023-04043, 2210968-2023-04042, 2210968-2024-04479 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 the local team received employee feedback about suspected products from on line sources.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGICEL ORIGINAL 4INX8IN(10.2CMX20.3CM)
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• 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: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19130232
• Report Number: 2210968-2024-04478
• Device Sequence Number: 17867672
• Product Code: LMG
• UDI-Device Identifier: 10705031003026
• UDI-Public: 10705031003026
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/17/2024

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 Expiration Date: 05/31/2021
• Device Catalogue Number: 1952
• Device Lot Number: KGB6651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2016
• 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