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

Model Number 1961

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/25/2021

Event Type  malfunction  

Event Description

A suspected product inquiry of (b)(6) during an ipo investigation.China supply chain checked and there was no record of the absorbable hemostat products.Additional information was requested.

Manufacturer Narrative

(b)(4).The following information was requested, but unavailable: - how was the product purchased? - 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? - was the device used on a patient? if so, was there any patient consequence? photo investigation summary: the packaging was observed to be according to the process specifications and the product was manufactured by ethicon, the diversion product is confirmed, since the ethicon product was not distributed by affiliate authorized.Investigation summary: the product was returned for evaluation.In a further investigation of the samples received, it was observed, that there was excessive carton damage and the artwork on the pouch and carton had added spacing mistakes.There were shading discrepancies on the carton when compared to approved artwork.The inside foil pouch appearance appears shinier than approved material appearance.In addition, it was noted time-stamp was identical for all packages of the same line.Based on the information currently available, counterfeit was identified during the investigation of the samples received.A manufacturing record evaluation was performed for the finished device lot, 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 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.; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15233575
• MDR Text Key: 305344916
• Report Number: 2210968-2022-06656
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031003118
• UDI-Public: 10705031003118
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2022

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 Model Number: 1961
• Device Catalogue Number: 1961
• Device Lot Number: RRB1325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1