MAUDE Adverse Event Report: ETHICON INC. SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1953
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: how were the products purchased? these products were purchased following listings in the internet is there any indication of the source? there is no indication of the sourcing.The following information was requested, but unavailable: is there an indication of how the product was distributed? were the devices used on a patient? if so, was there any patient consequence? investigation summary: this is an analysis for a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photos show two packages labeled 1953 and lot number tab1051, multiple discrepancies were identified.Overall, the package was confirmed as a counterfeit and diversion due to several visible errors.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch tab1051, 1953-34 and no non-conformances were identified.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 latin america global brand protection team has performed a test purchase in argentina due to a suspicious seller.The suture device was suspected of being diverted product from brazil, because this product is not approved in argentina.The absorbable hemostat was suspicious of being counterfeit.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SURGICEL ORIGINAL 2INX3IN(5.1CMX7.6CM)
• 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: 20185972
• Report Number: 2210968-2024-09480
• Device Sequence Number: 12811035
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• UDI-Public: (01)10705031003033(17)270831(10)TAB1051
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 09/10/2024

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: 1953
• Device Lot Number: TAB1051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/10/2024
• 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