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	05/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned.H 6.Investigation findings: c22 ¿ photo investigation.Attempts have been made to retrieve the device.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.Additional information was requested, and the following was obtained: ¿ how was the product purchased? online.¿ 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.¿ please confirm that no product is available for evaluation.Yes.The following information was requested, but unavailable: ¿ is there an indication of how the product was distributed? unknown.Photo investigation summary: this is an analysis of a photo sent to ethicon for evaluation.During the visual analysis the following was noted: the photos show an open box labeled as product code 1962 batch number ptr7632, a second image shows (b)(4) closed packages.Customer support services checked product traceability information but no sales records were found.In addition, the barcode qr was readable with the scanner with result ((b)(6), the last seven digits do not match with the lot number.Based on the samples received, the product is confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.The lot number ptr7632 printed on the box is not valid for batch records.Additional monitoring of complaint information for potential safety signals will be conducted through complaint trends as part of post-market surveillance.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 complain handling unit receive employee feedback about suspect absorbable hemostat products on an unknown date from an online source, (b)(6).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
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 20833131
• Report Number: 2210968-2024-12752
• Device Sequence Number: 8585093
• 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): 12/03/2024

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 Catalogue Number: 1962
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 12/03/2024
• 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
• Patient Sex: Unknown