MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 2INX4IN(5.1CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1962
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
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? local brand protection team purchased on line.Is there an indication of how the product was distributed? no.Is there any indication of the source? no.Based on the packaging, is there any indication of which market the original genuine product may have come from? no.Was the device used on a patient? if so, was there any patient consequence? no.Investigation summary: visual inspection was conducted on two box that product code 1962, lot rme1181.The team performed further analysis to determine if the complaint represented a suspected product.According to the results, the device was consistent in construction with surgicel.The device was consistent with surgicel by ftir.However, the device is consistent with recycled and/or expired surgicel fibrillar.All packages from this box had identical time-stamps.The box had shrinkwrap instead of cellophane.The box art and shading suspicious.Based on the investigation performed, it was determined that the product is counterfeit.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2023-06142, mw # 2210968-2023-06166, mw # 2210968-2023-06183, mw # 2210968-2023-06184, mw # 2210968-2023-06185, mw # 2210968-2023-06187, mw # 2210968-2023-06188.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
The suspected absorbable hemostat products were from six different online sources on an unknown date.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGICEL FIBRILLAR 2INX4IN(5.1CMX10.2CM)
• 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 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17623420
• Report Number: 2210968-2023-06186
• Device Sequence Number: 20372123
• Product Code: LMG
• UDI-Device Identifier: 10705031003125
• UDI-Public: 10705031003125
• 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): 08/25/2023

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: 08/31/2024
• Device Catalogue Number: 1962
• Device Lot Number: RME1181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2021
• 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