MAUDE Adverse Event Report: ETHICON INC. SURGICEL* 10X20CM; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 1902GB

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).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.Additional information was requested and the following was obtained: what is the lot number of each suspected product? the exact lot number of that suspected products is not clear to me.How many devices were used on patients? as per eg team feedback (attached) it is reported by surgeons that it had been used for multiple cases (estimated to be more that 10 cases).How many products were reported to not be properly absorbed by the patient post-op? as per eg team in market feedback (attached) it is suspected that it were not fully absorbed for 9 different cases.Please clarify were any infections confirmed? as per eg team feedback (attached) it is reported by surgeons (as per dr (b)(4) feedback) that it causes infection in multiple cases (more than 5 cases).If yes, how many cases of infection were reported/confirmed? more than 5 cases was there any medical or surgical intervention performed (product removed; re-operation; prescription medication)? if so, please specify.As per eg team feedback (attached) it is reported by dr (b)(6) in (b)(6) hospital that he performed redo surgery for product removal.How were the products purchased? that products were not purchased through our distributors in egypt (not current distributor egmed or old distributors) as that code is not registered in egypt moh.Is there an indication of how the products were distributed? that products may be available through illegal sources as medpay as per complaint raised before by my side and it was proven after investigation that it were counterfeit.Is there any indication of the source? n/a.Based on the packaging, is there any indication of which market the original genuine product may have come from? n/a.Photo investigation summary: one picture of one pouch from product code: (b)(4) was received for evaluation.An investigation was conducted to compare the artwork (fonts, size), printed variables, and bar codes to the released documents.Many discrepancies were found during the investigation.Event related to mw #: 2210968-2022-10621.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

It was reported that on an unknown date feedback was received from (b)(6) hospital in cairo having absorbable hemostat products not offered by company distributor.The product in question is not imported to the egyptian market through ethicon distributors and was not imported.There was the suspicion from the hospital surgeons that the product used was not fully absorbed and might cause infection.Additional information was requested.

• Type of Device: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; rue du puits godet 20; neuchatel CH-20 00; SZ CH-2000
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16044676
• MDR Text Key: 307791669
• Report Number: 2210968-2022-10620
• Device Sequence Number: 1
• Product Code: LMG
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2022

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 Catalogue Number: 1902GB
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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