MAUDE Adverse Event Report: ETHICON INC. SURGICEL POWDER USA - ABSORBABLE HEMOSTATIC PWDR; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number 3013SP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Inflammation (1932)

Event Date 11/13/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.The patient had osteomyelitis and performed surgery.Absorbable hemostat was sprayed for bleeding control and the clots are good looking.However, after that, there was an inflammatory reaction, and a lot of water came out while the patient stay hospital.The surgeon tried to re-op again and when the clot was examined again, and candida bacteria were found.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H6.Component code: g07002 - device not returned.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.1.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? 2.What are the name and date of index surgical procedure? 3.Please provide any relevant patient history: patient pre-existing medical conditions (i.E.Allergies, history of reactions), all concomitant medications, past medical history, any treatment required for events, dose, frequency, and therapy dates.4.Was there any intraoperative concurrent use of other products? 5.What is the lot number? 6.Where was the surgicel used (on what tissue)? 7.How much surgicel was used during the procedure? 8.Was the surgicel product left in place? was the excess irrigated and removed? 9.What were current symptoms following the index surgical procedure? onset date? 10.Were cultures performed? if yes, results? 11.Has any surgical or medical intervention been performed? 12.What is physician¿s opinion as to the cause of or contributing factors to this event? 13.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative inflammatory reaction? 14.What is the patient¿s current status? 15.What is the users experience w/ surgicel powder and other hemostatic agents? 16.Has the surgeon been advised to submit a medical information request regarding their inquiry, ¿the customer's request was that the surgicel powder prevents mrsa and mrse, but the surgeon was curious about how it forms a shield against candida bacteria.¿ 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 POWDER USA - ABSORBABLE HEMOSTATIC PWDR
• 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.-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: 18314946
• MDR Text Key: 330328092
• Report Number: 2210968-2023-09709
• Device Sequence Number: 1
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N12159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3013SP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• 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
• Patient Outcome(s): Required Intervention