MAUDE Adverse Event Report: Z-MEDICA, LLC QC HEMOSTATIC DRESSING, 4X4, 10X; DRESSING, WOUND, DRUG

Catalog Number	459
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as complainant did not report a lot number.The sample was not returned for investigation.It cannot be established if the customer was using a quikclot product or quikclot control+ product.Based on this a review of both product family ifus were reviewed.All quikclot product ifus state the product intended use is a topical dressing, must not remain in the wound for longer than 24 hours, and not for use in internal surgical procedures.All quikclot control+ product ifus state it is intended for temporary control of internal organ bleeding, it may also be used for control of surgical wounds, and do not leave in place for more than 48 hours.User did not follow ifu.Review of ifus show product was not used properly as contained in indications for use.(b)(4) will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: quick clot was left in patient for a year and was found on mri and mammogram.Provider was calling about information we have on leaving the product internal in a patient for extended amount of time.I informed her of the ifu we follow and product guidelines we teach.Follow up was provided from dan smith and provider was advised to remove the product since we dont have any literature to support long term placement of this product.

• Brand Name: QC HEMOSTATIC DRESSING, 4X4, 10X
• Common Device Name: DRESSING, WOUND, DRUG
• Manufacturer (Section D): Z-MEDICA, LLC; wallingford
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19653746
• Report Number: 3011137372-2024-00092
• Device Sequence Number: 12418164
• Product Code: FRO
• UDI-Device Identifier: 00841495104596
• UDI-Public: 00841495104596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: 459
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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