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

Catalog Number	3013SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4) d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: 1.What is the total number of cases over the past several months, where surgicel powder clogged several drains? 3 2.Have any of these cases previously been reported to ethicon? no please answer the below questions for each patient event: 3.Please provide the following patient demographic information, if available: age, gender, weight, bmi at the time of index procedure? all female 4.What are the name and date of index surgical procedure? two occurred in (b)(6) 2026.One (b)(6).No specific dates were provided.Axillary node dissection.5.What were the diagnosis and indication for the index surgical procedure? breast cancer.6.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.Unknown 7.Was there any intraoperative concurrent use of other products? no 8.What is the lot number? unknown.9.What was the intended use of the surgicel? was it used to address active bleeding or used prophylactically? some minor active oozing prior to close.Clarified wit surgeon her intent was to prevent post operative bleeding.Discussed vistaseal use.10.Where was the surgicel used (on what tissue)? soft tissue.11.How much surgicel was used during the procedure? unknown.12.Was the surgicel product left in place? was the excess irrigated and removed? irrigated prior to placing drains.13.What were current symptoms following the index surgical procedure? what was the onset date? clogged drains.14.Has any surgical or medical intervention been performed? developed seroma 15.What is physician¿s opinion as to the cause of this event? clogged drains.16.Was there an alleged deficiency of the surgicel that contributed to the patient¿s post-operative event? unknown.Efficacy not questioned.It is the post op drain clogging from the product.17.What is the patient¿s current status? stable 18.What is the users experience w/ surgicel powder and other hemostatic agents? new user to surgicel powder.Previous arista user.19.Did they remove surgicel powder prior to placing it near the drains.Yes 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 or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and absorbable hemostat was used.It was reported by the surgeon that the absorbable hemostat has clogged several drains in the past several months post op.Removal of drain has been performed.Surgical delay was unknown.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4).Additional information was requested, and the following was obtained: *can you clarify the intent of the surgicel powder.Was it used for active bleeding or for post op bleeding? per surgeon there was some minimal oozing.However, her intent was post operative bleeding prevention.*was the drain placed in the area that the surgicel was used? drain placed adjacent to product.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 HEMOSTA
• 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 PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24363885
• Report Number: 2210968-2026-01661
• Device Sequence Number: 9679258
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 3013SP
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female