MAUDE Adverse Event Report: Ethicon Inc. ETHIZIA; Agent, absorbable hemostatic, collagen based

Catalog Number	HSP510
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and hemostatic patch was used.During the procedure, the product was breaking apart, and no coagulation could be achieved.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #(b)(4) d4: udi: the expiration date is currently not available.Therefore, 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.The following information was requested, but unavailable: was there any reported patient or user harm? unknown , was there a significant delay? unknown.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.Did the reported issue contribute to any patient adverse consequences? how was the surgery completed? was there any additional medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Could you tell me if there was a prescription for steroids or antibiotics for the patient¿s recovery? if yes, please provide medication name, route and dose.What is the current status of the patient? do you have any photos available for visual analysis? could you please provide the lot number? 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: ETHIZIA
• Common Device Name: Agent, absorbable hemostatic, collagen based
• Manufacturer (Section D): Ethicon Inc.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): GATT Technologies BV ; transistorweg 5; nijmegen 6534 AT; NL 6534 AT
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; +1(303)552-6892
• MDR Report Key: 50949010
• Report Number: 2210968-2026-09965
• Device Sequence Number: 18547700
• Product Code: SGV
• UDI-Device Identifier: 10705031471214
• UDI-Public: 10705031471214
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P240035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: HSP510
• Device Lot Number: 0000400917
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sex: Unknown