MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1961

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #
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> (b)(4) h6.Component code: g07002 - device not returned h 6.Investigation findings: c22 ¿ photo investigation 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.Photo investigation summary
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> this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows an open box and ten packs of the 1961 product.Analysis of the photo showed multiple discrepancies in the labeling, such as the writing style and font of the product illustration did not match the information in the file.The ethicon raritan 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 recycled and/or expired surgicel fibrillar.No suitable control 1961 product for box ((b)(6)), but box is counterfeit for missing certain features.No suitable control 1961 product for package (lab001170v4), but package is counterfeit because of several visible errors.Based on the investigation performed, it was determined that the product is counterfeit, diversion was confirmed.Ethicon products were not distributed by authorized affiliates.A manufacturing record evaluation could not be completed as sab1070 batch is invalid.Event related to mw # 2210968-2024-01528, mw # 2210968-2024-01530, mw # 2210968-2024-01531, mw # 2210968-2024-01532 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 Description

The complaint handling unit received employee feedback about suspected absorbable hemostat product from three online sources; shandong jianhu medical technology co., ltd shandong yingzhitai medical technology co., ltd zhongshan kunertai electronic equipment co., ltd.No adverse patient consequences were reported.

• Brand Name: SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM)
• Type of Device: 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: 18727347
• MDR Text Key: 336630145
• Report Number: 2210968-2024-01529
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 1961
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1