MAUDE Adverse Event Report: ETHICON INC. SURGICEL FIBRILLAR 4X4IN(10.2CMX10.2CM); AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	1963
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a thoracic and lumbar spine surgery and debridement and drainage procedure on (b)(6) 2025 and absorbable hemostat was used.The patient underwent surgery due to thoracolumbar vertebrae.During the surgery, antibiotics, artificial bone, hemostatic fluid gelatin, and hemostatic gauze were used, and the instruments were used smoothly.The patient was discharged.50 days after surgery, the patient developed wound infection and was readmitted to the hospital.The wound was cleaned and washed, and surgery was performed.Currently discharged from the hospital.Additional information was requested.
Additional 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.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 were the diagnosis and indication for the 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.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? 5.Where was the surgicel used (on what tissue)? 6.How much surgicel was used during the procedure? 7.How much surgiflo was used? 8.Was the surgicel product left in place? was the excess removed? 9.Was surgiflo removed or left in the patient after hemostasis? 10.What were current symptoms following the index surgical procedure? what was the onset date? 11.Were cultures performed? if yes, results? 12.Has any surgical or medical intervention been performed? 13.What is the surgeon¿s opinion of why the patient experienced an infection? 14.Was there an alleged deficiency of the surgicel or surgiflo that contributed to the patient¿s post-operative infection? 15.What is the patient¿s current status? 16.What is the users experience w/ surgicel and other hemostatic agents? 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6.A manufacturing record evaluation was performed for the finished device 1062hd / 1963 batch number, 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 4X4IN(10.2CMX10.2CM)
• 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; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 23692662
• Report Number: 2210968-2025-13356
• Device Sequence Number: 10215934
• Product Code: LMG
• UDI-Device Identifier: 10705031003132
• UDI-Public: (01)10705031003132(17)271031(10)1062HD
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1963
• Device Lot Number: 1062HD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown