MAUDE Adverse Event Report: Ethicon Inc. SURGICEL; 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	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the complaint handling unit received feedback from an employee about suspected counterfeit products from online sources.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4/g4: device is not distributed in the united states, but is similar to device marketed in the usa.Therefore, (01)gtin is not available.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.The following information was requested, but unavailable: received information as following from reporter via phone today.Please refer to the event description, other information requested is unknown.1.Could you please confirm if the vendor is authorized by jnj? 2.How was the product purchased? 3.Is there an indication of how the product was distributed? 4.Is there any indication of the source? 5.Based on the packaging, is there any indication of which market the original genuine product may have come from? photo investigation summary.This is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis, the following was observed: the photo shows 12 packages identified with product code 1953; batch number 103gtp, expiration date 2029-31-07 with identical time/lane marks (17:18:48 l2) on all bags.As the device was not returned, an analysis investigation could not be performed.The photos show multiple labeling discrepancies that there are identical time/lane markings (17:18:48 l2) across all of the pouches.Based on the samples received, the product is confirmed to be counterfeit due to the discrepancies found in the labeling and packaging material.Device history review.A manufacturing record evaluation was performed for the finished device batch 103gtp, 1953-12 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.

• Brand Name: SURGICEL
• 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 ; PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50945983
• Report Number: 2210968-2026-09921
• Device Sequence Number: 10451982
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 103GTP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• 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