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

Catalog Number	1953
Medical Device Problem Codes	Device Markings/Labelling Problem (2911); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information was requested, and the following was obtained: is this a report of suspect counterfeit or suspect diversion? maybe counterfeit or diversion.How was the product purchased?--hospital purchased by themselves.Was the device used on a patient? if so, was there any patient consequence? no.The following information was requested, but unavailable: is there an indication of how the product was distributed? is there any indication of the source? based on the packaging, is there any indication of which market the original genuine product may have come from? investigation summary: visual inspection was conducted on one box with twelve samples that pertain to product code 1953, lot rgb5391.The samples were received at ethicon raritan team and performed further analysis to determine if the complaint represented a suspect diversion and suspect counterfeit.According to the results, the artwork prints on the box were compared within the ethicon system and no anomalies were noted.However, all pouch foil packages from this box had identical time stamps.Upon visual revision of the traceability report the lot was sold j&j china the diversion product could not be confirmed; but the counterfeit is confirmed.Based on the investigation performed, it was determined that the product is counterfeit.A manufacturing record evaluation was performed for the finished device batch 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
It was reported that the local team received feedback that there are suspected absorbable hemostat products in the market.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: 20892852
• Report Number: 2210968-2024-13120
• Device Sequence Number: 8709761
• Product Code: LMG
• UDI-Device Identifier: 10705031003033
• UDI-Public: (01)10705031003033(17)260228(10)RGB5391
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 1953
• Device Lot Number: RGB5391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2021
• 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