MAUDE Adverse Event Report: Z-MEDICA, LLC QC HEMO DRESSING 4"X4",MULTI-LANG,CE,10X; DRESSING, WOUND, DRUG

Catalog Number	301
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn #: (b)(4).Based upon the findings contained in this complaint review it does not appear that the item had the potential for inability to perform as intended.In the ifu it states "apply dressing directly to the source of the bleeding and use it to apply manual compression.More than one dressing may be required.Continue to apply manual pressure for 5 minutes, or until bleeding is controlled." based upon the customer reply stating the "patient was lying in a pool of blood" possibly indicates that the hemostatic bandage was not used per ifu.Dhr review found no issues that could cause or contribute to this complaint.
Event or Problem Description
It was reported that, "patient's permcath insertion site was bleeding and the quikclot did not help to stop the bleeding.Patient is still in surgical ward; bleeding is currently under control.It looks like the bleeding occurred in icu over the weekend.The doctor gave something to stop help stop the bleeding.".

• Brand Name: QC HEMO DRESSING 4"X4",MULTI-LANG,CE,10X
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC; wallingford
• Manufacturer (Section G): Z-MEDICA, LLC; 4 fairfield blvd., suite 1; wallingford
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22344145
• Report Number: 3004138549-2025-00004
• Device Sequence Number: 17336366
• Product Code: FRO
• UDI-Device Identifier: 10841495150286
• UDI-Public: (01)10841495150286(11)231102(17)270202(10)44F23L0004(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K123387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2025

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: 301
• Device Lot Number: 44F23L0004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Patient Sex: Unknown